Mode
Text Size
Log in / Sign up
Phase 1 Completed N=33 Randomized Treatment

A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants

Source: ClinicalTrials.gov NCT04827134 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Cohort 1: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC [0-inf]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions — 59140; 67210; 8565; 9986 Hours*nanogram per milliliter

Summary

This study will assess the effect of food on the pharmacokinetics (PK) of pediatric formulations of TRIUMEQ (dolutegravir [DTG] 5 milligrams [mg]/abacavir [ABC] 60 mg/lamivudine [3TC] 30 mg) dispersible tablets and DOVATO (DTG 5 mg/3TC 30 mg) dispersible tablets in healthy adult participants. Additionally, safety and tolerability of these formulations will also be assessed. TRIUMEQ and DOVATO are registered trademarks of GlaxoSmithKline group of companies.

Outcome Measures

OutcomeResultp-value
PRIMARY
Cohort 1: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC [0-inf]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
59140; 67210; 8565; 9986; 6508; 7295
PRIMARY
Cohort 1: AUC From Time Zero to Time of Last Observed Quantifiable Concentration (AUC [0-t]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
55770; 63790; 8501; 9923; 6319; 7182
PRIMARY
Cohort 1: Maximum Observed Concentration (Cmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
2359; 3322; 1837; 4080; 886.9; 1392
PRIMARY
Cohort 2: AUC (0-inf) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
47830; 51800; 6975; 7864
PRIMARY
Cohort 2: AUC (0-t) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
46060; 49690; 6799; 7762
PRIMARY
Cohort 2: Cmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
2331; 3131; 1084; 2066
SECONDARY
Cohort 1: Lag Time for Absorption (Tlag) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
0.000; 0.000; 0.000; 0.000; 0.000; 0.000
SECONDARY
Cohort 1: Terminal Elimination Phase Half-life (t1/2) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
16.18; 16.10; 2.291; 1.958; 17.35; 15.23
SECONDARY
Cohort 1: AUC From Time Zero to 24 Hours (AUC[0-24]) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
36380; 43870; 8553; 9980; 5817; 6707
SECONDARY
Cohort 1: Last Quantifiable Concentration (Ct) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
122.2; 128.6; 10.61; 17.51; 5.280; 4.621
SECONDARY
Cohort 1: Concentration at 24 Hours Post-dose (C24) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
958.6; 996.3; 4.833; 3.814; 23.40; 21.74
SECONDARY
Cohort 1: Time of Maximum Observed Concentration (Tmax) of DTG, ABC and 3TC Following Administration of TRIUMEQ Under Fed and Fasted Conditions
5.000; 1.250; 2.750; 0.500; 3.500; 1.508
SECONDARY
Cohort 2: Tlag of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
0.000; 0.000; 0.000; 0.000
SECONDARY
Cohort 2: t1/2 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
14.43; 15.12; 18.47; 18.36
SECONDARY
Cohort 2: AUC(0-24) of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
32620; 35360; 6339; 7339
SECONDARY
Cohort 2: Ct of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
82.37; 79.73; 4.078; 3.622
SECONDARY
Cohort 2: C24 of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
764.7; 715.4; 22.56; 20.38
SECONDARY
Cohort 2: Tmax of DTG and 3TC Following Administration of DOVATO Under Fed and Fasted Conditions
4.000; 0.875; 3.000; 0.750
SECONDARY
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
1; 3; 1; 1; 0; 0
SECONDARY
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
-0.002; -0.004; -0.003; 0.001; -0.002; 0.015
SECONDARY
Change From Baseline in Hematology Parameters: Red Blood Cell (RBC) Count
0.008; -0.006; 0.024; 0.018
SECONDARY
Change From Baseline in Hematology Parameters: Hemoglobin
0.3; -1.1; 1.2; -0.1
SECONDARY
Change From Baseline in Hematology Parameters: Hematocrit
-0.0001; 0.0003; 0.0006; 0.0010
SECONDARY
Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume
-0.09; 0.12; -0.28; -0.14
SECONDARY
Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
-0.03; -0.24; 0.13; -0.09
SECONDARY
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and Neutrophil
0.040; 0.043; 0.042; 0.041; 0.038; 0.039
SECONDARY
Absolute Values of Hematology Parameters: RBC Count
4.648; 4.684; 4.765; 4.848; 4.656; 4.678
SECONDARY
Absolute Values of Hematology Parameters: Hemoglobin
133.5; 134.4; 142.0; 144.5; 133.8; 133.3
SECONDARY
Absolute Values of Hematology Parameters: Hematocrit
0.3957; 0.3976; 0.4163; 0.4227; 0.3956; 0.3979
SECONDARY
Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Volume
85.11; 84.92; 87.64; 87.45; 85.02; 85.04
SECONDARY
Absolute Values of Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin
28.74; 28.71; 29.89; 29.89; 28.71; 28.48
SECONDARY
Change From Baseline in Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST)
4.0; -5.1; -0.4; -3.6; -2.6; -3.0
SECONDARY
Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN)
-0.003; -0.034; 0.029; 0.038; -0.037; -0.169
SECONDARY
Change From Baseline in Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin
9.18; 10.76; 1.83; 2.11; 0.16; 0.05
SECONDARY
Change From Baseline in Clinical Chemistry Parameters: Creatine Kinase
-17.8; -51.9; -33.9; -29.5
SECONDARY
Change From Baseline in Clinical Chemistry Parameters: Albumin and Total Protein
0.2; -0.9; 0.9; 1.1; 0.9; -0.2
SECONDARY
Absolute Values of Clinical Chemistry Parameters: ALT, ALP and AST
19.7; 24.3; 23.4; 24.8; 23.7; 19.3
SECONDARY
Absolute Values of Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and BUN
2.350; 2.376; 2.339; 2.333; 2.347; 2.342
SECONDARY
Absolute Values of Clinical Chemistry Parameters: Creatinine, Direct Bilirubin and Total Bilirubin
74.38; 75.10; 80.18; 82.54; 83.55; 85.86
SECONDARY
Absolute Values of Clinical Chemistry Parameters: Creatine Kinase
111.5; 143.8; 119.7; 124.6; 93.7; 91.8
SECONDARY
Absolute Values of Clinical Chemistry Parameters: Albumin and Total Protein
44.0; 44.5; 43.0; 42.9; 44.2; 43.6
SECONDARY
Change From Baseline in Urinalysis Parameter: Specific Gravity
0.0034; 0.0013; 0.0029; 0.0019
SECONDARY
Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick
-0.34; -0.22; -0.13; -0.44
SECONDARY
Absolute Values of Urinalysis Parameter: Specific Gravity
1.0128; 1.0134; 1.0151; 1.0163; 1.0162; 1.0147
SECONDARY
Absolute Values of Urinalysis Parameter: Potential of Hydrogen (pH) by Dipstick
6.38; 6.22; 6.41; 6.50; 6.03; 6.00
SECONDARY
Number of Participants With Abnormal Values on Urinalysis by Dipstick
16; 16; 17; 16; 16; 16
SECONDARY
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT Interval According to Fridericia's Formula (QTcF)
2.2; -0.7; -2.7; 4.0; -1.2; -2.9
SECONDARY
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF
163.4; 161.6; 174.6; 176.1; 165.6; 160.9
SECONDARY
Change From Baseline in Vital Signs Measurements: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
-1.1; -4.2; 1.9; 0.6; 0.0; 0.3
SECONDARY
Absolute Values of Vital Signs Measurements: SBP and DBP
110.6; 113.0; 112.5; 113.5; 109.5; 108.8
SECONDARY
Change From Baseline in Vital Signs Measurements: Pulse Rate
3.0; -0.3; 1.1; -0.1
SECONDARY
Absolute Values of Vital Signs Measurements: Pulse Rate
59.9; 62.3; 59.9; 60.1; 62.9; 62.0

Eligibility Criteria

Inclusion Criteria

  • Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
  • Participants 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 >=50.0 kilograms (kg) (110 pounds [lbs.]) for males and >=45 kg (99 lbs.) for females and body mass index within the range 18.5 to 31.0 kilogram per meter square (kg/m^2, inclusive).
  • A male participant is eligible to participate if they agree to use contraceptive methods.
  • A female participant is eligible to participate if she is not pregnant (, not lactating or breastfeeding, and at least 1 of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a non-hormonal contraceptive method that is highly effective
  • Capable of giving signed informed consent
  • Documentation that the participant is negative for the human leukocyte antigen (HLA) B*5701 allele.

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).
  • Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome.
  • A pre-existing condition interfering with normal gastrointestinal 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 intervention.
  • QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 milliseconds (msec).
  • A participant with known or suspected active coronavirus disease (COVID-19) infection OR contact with an individual with known COVID-19, within 14 days of study enrollment.
  • Presence of hepatitis B surface antigen at screening or within 3 months prior to starting study intervention.
  • Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention AND positive on reflex to hepatitis C ribonucleic acid (RNA).
  • Positive human immunodeficiency virus (HIV)-1 and -2 antigen/antibody immunoassay at screening.
  • Alanine aminotransferase (ALT) >1.5 × upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility.
  • Bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin 14 units for males or >7 drinks for females.
  • Unable to refrain from tobacco or nicotine-containing products within 1 month prior to screening.
  • History of sensitivity, prior intolerance or hypersensitivity to any of the study interventions, 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 (NCT04827134). 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.

Back to search