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Phase 1 Completed N=16 Treatment

Study to Evaluate the Pharmacokinetic (PK) Interactions Between GSK3640254 and Dolutegravir (DTG)

Source: ClinicalTrials.gov NCT03816696 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing (AUC[0 to Tau]) of Dolutegravir for Dolutegravir Arm — 64627.8 Hours* nanogram per milliliter

Summary

This is an open-label, single-sequence, two-way drug interaction study to investigate the PK, safety and tolerability of GSK3640254 and DTG when administered alone or in combination in healthy subjects. Treatment of human immunodeficiency virus (HIV) infection frequently involves combination therapy. Data from this study will contribute to dosing recommendations when GSK3640254 and DTG are given in combination. The study will consist of a Screening period and 3 sequential treatment periods. Subjects will be administered DTG 50 milligrams (mg) once daily (QD) in Period 1 followed by GSK3640254 200 mg QD in Period 2. There will be a washout period of 4 days between Periods 1 and 2. In Period 3, subjects will be co-administered DTG 50 mg QD and GSK3640254 200 mg QD. The total duration of the study will be approximately 55 days, including Screening.

Outcome Measures

OutcomeResultp-value
PRIMARY
Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing (AUC[0 to Tau]) of Dolutegravir for Dolutegravir Arm
64627.8
PRIMARY
Period 3: AUC(0 to Tau) of Dolutegravir for Dolutegravir + GSK3640254 Arm
75860.5
PRIMARY
Period 1: Maximum Observed Concentration (Cmax) of Dolutegravir for Dolutegravir Arm
4962
PRIMARY
Period 3: Cmax of Dolutegravir for Dolutegravir + GSK3640254 Arm
5408
PRIMARY
Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of Dolutegravir for Dolutegravir Arm
1373
PRIMARY
Period 3: Ctau of Dolutegravir for Dolutegravir + GSK3640254 Arm
1696
PRIMARY
Period 2: AUC(0 to Tau) of GSK3640254 for GSK3640254 Arm
26.72
PRIMARY
Period 3: AUC(0 to Tau) of GSK3640254 for Dolutegravir + GSK3640254 Arm
27.84
PRIMARY
Period 2: Cmax of GSK3640254 for GSK3640254 Arm
1.676
PRIMARY
Period 3: Cmax of GSK3640254 for Dolutegravir + GSK3640254 Arm
1.662
PRIMARY
Period 2: Ctau of GSK3640254 for GSK3640254 Arm
0.8583
PRIMARY
Period 3: Ctau of GSK3640254 for Dolutegravir + GSK3640254 Arm
0.8549
SECONDARY
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
1; 3; 2; 0; 0; 0
SECONDARY
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
-0.003; 0.046; 0.013; -0.020; -0.217; -6.5
SECONDARY
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
-0.006; -0.026; -0.154; -0.024; -0.160; -6.0
SECONDARY
Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
0.003; 0.007; 0.003; -0.001; 0.004; -0.036
SECONDARY
Period 1: Change From Baseline in Hematology Parameter: Hemoglobin
4.4
SECONDARY
Period 2: Change From Baseline in Hematology Parameter: Hemoglobin
0.1
SECONDARY
Period 3: Change From Baseline in Hematology Parameter: Hemoglobin
3.3; 0.6; 1.2
SECONDARY
Period 1: Change From Baseline in Hematology Parameter: Hematocrit
0.0178
SECONDARY
Period 2: Change From Baseline in Hematology Parameter: Hematocrit
-0.0013
SECONDARY
Period 3: Change From Baseline in Hematology Parameter: Hematocrit
0.0035; -0.0049; -0.0041
SECONDARY
Period 1: Change From Baseline in Hematology Parameter: Erythrocytes
0.170
SECONDARY
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes
0.036
SECONDARY
Period 3: Change From Baseline in Hematology Parameter: Erythrocytes
0.016; -0.079; -0.054
SECONDARY
Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
0.63
SECONDARY
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
-0.86
SECONDARY
Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
0.40; 0.36; 0.05
SECONDARY
Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
-0.11
SECONDARY
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
-0.17
SECONDARY
Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
0.55; 0.55; 0.52
SECONDARY
Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
0.063; 0.088; -0.084; -1.2; 0.025; -0.1
SECONDARY
Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
-0.249; -0.269; 0.087; 2.2; 0.014; -1.3
SECONDARY
Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
0.062; 0.103; -0.066; 0.096; -0.008; -0.030
SECONDARY
Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase
-32.0; -21.9; -0.3; -0.1; -0.7; -2.1
SECONDARY
Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
22.6; 9.1; -0.6; 1.9; 0.2; -0.8
SECONDARY
Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
-32.1; -37.1; -42.1; 5.9; -0.9; 0.1
SECONDARY
Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
-32.3; 5.41; 0.01; 0.03
SECONDARY
Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
-7.1; -3.36; 0.27; 0.06
SECONDARY
Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
0.0; -15.6; -1.4; 7.90; 9.89; 1.99
SECONDARY
Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
0.4; 0.8; 1.2
SECONDARY
Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
0.9; -1.1; -0.2
SECONDARY
Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein
0.9; 0.2; 0.4; -0.9; 1.0; 0.5
SECONDARY
Period 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase
3.1; -3.4
SECONDARY
Period 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
-2.8; -0.7
SECONDARY
Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase
-1.6; 0.1; -0.9; 4.7; -0.8; 0.1
SECONDARY
Period 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
0.0053
SECONDARY
Period 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
-0.0004
SECONDARY
Period 3: Change From Baseline in Urinalysis Parameter: Specific Gravity
0.0003; -0.0007; -0.0016
SECONDARY
Period 1: Change From Baseline in Urinalysis Parameter: Urobilinogen
0.0000
SECONDARY
Period 2: Change From Baseline in Urinalysis Parameter: Urobilinogen
0.0000
SECONDARY
Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen
0.0000; 0.0000; 0.0000
SECONDARY
Period 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH)
-0.22
SECONDARY
Period 2: Change From Baseline in Urinalysis Parameter: pH
0.13
SECONDARY
Period 3: Change From Baseline in Urinalysis Parameter: pH
0.03; -0.13; 0.16
SECONDARY
Period 1: Number of Participants With Urinalysis Dipstick Results
16; 16; 15; 1; 16; 16
SECONDARY
Period 2: Number of Participants With Urinalysis Dipstick Results
16; 16; 15; 1; 15; 1
SECONDARY
Period 3: Number of Participants With Urinalysis Dipstick Results
16; 16; 16; 16; 16; 16
SECONDARY
Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)
-0.5; 1.7; 4.7; 1.3; 1.9; 1.8
SECONDARY
Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
-3.3; -3.0; -2.1; -3.4; -6.4; 0.1
SECONDARY
Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB
1.9; -1.9; -0.4; 0.9; -2.9; -1.4
SECONDARY
Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
3.5; -0.4; 3.7; -6.2; 4.3; 0.9
SECONDARY
Period 2: Change From Baseline in SBP and DBP
1.7; 1.3; 3.0; -0.5; -0.1; 0.6
SECONDARY
Period 3: Change From Baseline in SBP and DBP
-0.1; -3.4; -3.3; 3.6; -1.4; -2.1
SECONDARY
Period 1: Change From Baseline in Pulse Rate
-0.3; -1.3; 2.0; -1.6
SECONDARY
Period 2: Change From Baseline in Pulse Rate
3.9; 5.4; 4.8; 4.2; 3.8; 2.7
SECONDARY
Period 3: Change From Baseline in Pulse Rate
1.8; 2.2; 0.3; 3.1; 1.3; -2.1
SECONDARY
Period 1: Change From Baseline in Respiratory Rate
-0.9; 0.3; -1.5; -0.8
SECONDARY
Period 2: Change From Baseline in Respiratory Rate
-0.5; 0.4; -0.6; 1.3; -0.4; 0.1
SECONDARY
Period 3: Change From Baseline in Respiratory Rate
1.4; 0.5; 0.3; -0.5; 0.6; 0.3
SECONDARY
Period 1: Change From Baseline in Body Temperature
-0.04; -0.14; -0.19; 0.03
SECONDARY
Period 2: Change From Baseline in Body Temperature
-0.14; -0.25; -0.19; -0.05; -0.13; -0.13
SECONDARY
Period 3: Change From Baseline in Body Temperature
-0.08; -0.18; 0.02; 0.00; -0.03; 0.06
SECONDARY
Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
0.045; 0.232; 2.023; 0.512; 3.038; 270.2
SECONDARY
Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
0.039; 0.206; 1.869; 0.488; 2.878; 264.2
SECONDARY
Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count
0.043; 0.046; 0.042; 0.206; 0.211; 0.171
SECONDARY
Period 1: Absolute Values for Hematology Parameter: Hemoglobin
146.4
SECONDARY
Period 2: Absolute Values for Hematology Parameter: Hemoglobin
146.5
SECONDARY
Period 3: Absolute Values for Hematology Parameter: Hemoglobin
149.8; 147.1; 147.7
SECONDARY
Period 1: Absolute Values for Hematology Parameter: Hematocrit
0.4419
SECONDARY
Period 2: Absolute Values for Hematology Parameter: Hematocrit
0.4406
SECONDARY
Period 3: Absolute Values for Hematology Parameter: Hematocrit
0.4441; 0.4357; 0.4364
SECONDARY
Period 1: Absolute Values for Hematology Parameter: Erythrocytes
5.143
SECONDARY
Period 2: Absolute Values for Hematology Parameter: Erythrocytes
5.179
SECONDARY
Period 3: Absolute Values for Hematology Parameter: Erythrocytes
5.194; 5.099; 5.124
SECONDARY
Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
86.22
SECONDARY
Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
85.36
SECONDARY
Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
85.76; 85.72; 85.41
SECONDARY
Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
28.58
SECONDARY
Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
28.41
SECONDARY
Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
28.96; 28.96; 28.93
SECONDARY
Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
5.165; 4.456; 1.107; 9.2; 2.393; 30.5
SECONDARY
Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
4.916; 4.187; 1.194; 11.4; 2.406; 29.3
SECONDARY
Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
4.978; 5.018; 4.849; 4.283; 4.179; 4.157
SECONDARY
Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
101.3; 107.4; 21.0; 57.4; 16.6; 21.1
SECONDARY
Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
123.9; 116.5; 20.4; 59.3; 16.8; 20.3
SECONDARY
Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase
110.3; 105.3; 100.3; 122.4; 115.6; 116.6
SECONDARY
Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
321.9; 90.28; 9.14; 1.87
SECONDARY
Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
314.8; 86.92; 9.41; 1.93
SECONDARY
Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin
314.8; 299.3; 313.4; 94.82; 96.81; 88.91
SECONDARY
Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
44.1; 27.9; 71.9
SECONDARY
Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
44.9; 26.8; 71.8
SECONDARY
Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein
45.9; 45.1; 45.3; 25.9; 27.8; 27.3
SECONDARY
Period 1: Absolute Values for Chemistry Parameters: Amylase, Lipase
59.6; 22.4
SECONDARY
Period 2: Absolute Values for Chemistry Parameters: Amylase, Lipase
56.8; 21.7
SECONDARY
Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase
55.3; 56.9; 55.9; 26.4; 20.9; 21.8
SECONDARY
Period 1: Absolute Values for Urinalysis Parameter: Specific Gravity
1.0181
SECONDARY
Period 2: Absolute Values for Urinalysis Parameter: Specific Gravity
1.0176
SECONDARY
Period 3: Absolute Values for Urinalysis Parameter: Specific Gravity
1.0179; 1.0169; 1.0160
SECONDARY
Period 1: Absolute Values for Urinalysis Parameter: Urobilinogen
3.3860
SECONDARY
Period 2: Absolute Values for Urinalysis Parameter: Urobilinogen
3.3860
SECONDARY
Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen
3.3860; 3.3860; 3.3860
SECONDARY
Period 1: Absolute Values for Urinalysis Parameter: pH
5.88
SECONDARY
Period 2: Absolute Values for Urinalysis Parameter: pH
6.00
SECONDARY
Period 3: Absolute Values for Urinalysis Parameter: pH
6.03; 5.88; 6.16
SECONDARY
Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
159.1; 161.3; 164.3; 160.9; 161.5; 95.2
SECONDARY
Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
165.1; 165.4; 166.3; 165.0; 162.0; 94.1
SECONDARY
Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB
167.9; 164.1; 165.6; 166.9; 163.1; 164.6
SECONDARY
Period 1: Absolute Values for SBP and DBP
118.8; 114.9; 119.0; 109.1; 76.1; 72.7
SECONDARY
Period 2: Absolute Values for SBP and DBP
115.8; 115.3; 117.1; 113.6; 113.9; 114.6
SECONDARY
Period 3: Absolute Values for SBP and DBP
115.8; 112.5; 112.6; 119.4; 114.4; 113.8
SECONDARY
Period 1: Absolute Values for Pulse Rate
67.8; 66.8; 70.1; 66.4
SECONDARY
Period 2: Absolute Values for Pulse Rate
68.3; 69.7; 69.1; 68.5; 68.1; 67.0
SECONDARY
Period 3: Absolute Values for Pulse Rate
68.4; 68.9; 66.9; 69.8; 67.9; 64.6
SECONDARY
Period 1: Absolute Values for Respiratory Rate
13.5; 14.6; 12.9; 13.6
SECONDARY
Period 2: Absolute Values for Respiratory Rate
13.6; 14.5; 13.5; 15.3; 13.8; 14.3
SECONDARY
Period 3: Absolute Values for Respiratory Rate
15.0; 14.1; 13.9; 13.1; 14.3; 13.9
SECONDARY
Period 1: Absolute Values for Body Temperature
36.36; 36.26; 36.21; 36.43
SECONDARY
Period 2: Absolute Values for Body Temperature
36.26; 36.15; 36.21; 36.35; 36.28; 36.28
SECONDARY
Period 3: Absolute Values for Body Temperature
36.33; 36.22; 36.42; 36.40; 36.37; 36.46
SECONDARY
Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 for GSK3640254 Arm
5.000
SECONDARY
Period 3: Tmax of GSK3640254 for Dolutegravir + GSK3640254 Arm
5.000
SECONDARY
Period 2: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 for GSK3640254 Arm
NA
SECONDARY
Period 3: T1/2 of GSK3640254 for Dolutegravir + GSK3640254 Arm
23.417
SECONDARY
Period 1: Tmax of Dolutegravir for Dolutegravir Arm
3.000
SECONDARY
Period 3: Tmax of Dolutegravir for Dolutegravir + GSK3640254 Arm
3.000
SECONDARY
Period 1: T1/2 of Dolutegravir for Dolutegravir Arm
14.492
SECONDARY
Period 3: T1/2 of Dolutegravir for Dolutegravir + GSK3640254 Arm
14.690

Eligibility Criteria

Inclusion Criteria

  • Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
  • Subjects who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
  • Body weight >=50 kilograms (kg) (110 pounds [lbs]) for men and >=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 31.0 kilograms per square meter (kg/m^2) (inclusive).
  • Male or female subjects can participate. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP).
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.

Exclusion Criteria

  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A pre-existing condition interfering with normal gastrointestinal (GI) anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs or render the subject unable to take oral study intervention.
  • Any history of significant underlying psychiatric disorder, including but not limited to schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder.
  • Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment. Subjects with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy ( 1.5 times upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility.
  • Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin 100 beats per minute [bpm] and females: 100 bpm); PR interval ( 200 milliseconds [msec]); QRS duration ( 110 msec); QTcF interval (males: >450 msec and females: >470 msec).
  • History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 units. One unit is equivalent to 8 grams of alcohol: a half-pint (equivalent to 240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits.
  • Regular use of tobacco- or nicotine-containing products within 3 months prior to Screening.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03816696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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