Phase 1
N=14
Drug-drug Interaction Study of Gepotidacin
Infections, Bacterial
Bottom Line
View on ClinicalTrials.gov: NCT04493931 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Cohort 1: Maximum Observed Concentration (Cmax) of Gepotidacin in Plasma — 4.817; 4.548 Micrograms per milliliter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Gepotidacin (Drug); Cimetidine (Drug); Rifampicin (Drug); Midazolam (Drug); Digoxin (Drug); Placebo matching to gepotidacin (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: Maximum Observed Concentration (Cmax) of Gepotidacin in Plasma |
4.817; 4.548 | — |
| PRIMARY Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of Gepotidacin in Plasma |
2.500; 2.500 | — |
| PRIMARY Cohort 1: Terminal Phase Half-life (t1/2) of Gepotidacin in Plasma |
11.344; 12.415 | — |
| PRIMARY Cohort 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Gepotidacin in Plasma |
20.3; 23.4 | — |
| PRIMARY Cohort 1: AUC From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Gepotidacin in Plasma |
20.6; 23.9 | — |
| PRIMARY Cohort 2: Cmax of Gepotidacin in Plasma |
3.735; 2.728 | — |
| PRIMARY Cohort 2: Lag Time Before Observation of Drug Concentrations (Tlag) of Gepotidacin in Plasma |
0.000; 0.000 | — |
| PRIMARY Cohort 2: Tmax of Gepotidacin in Plasma |
2.500; 2.000 | — |
| PRIMARY Cohort 2: AUC(0-t) of Gepotidacin in Plasma |
19.0; 9.0 | — |
| PRIMARY Cohort 2: AUC(0-infinity) of Gepotidacin in Plasma |
19.3; 9.3 | — |
| PRIMARY Cohort 3: Cmax of Digoxin in Plasma |
1553.135; 2381.259 | — |
| PRIMARY Cohort 3: Tlag of Digoxin in Plasma |
0.000; 0.000 | — |
| PRIMARY Cohort 3: Tmax of Digoxin in Plasma |
2.000; 1.275 | — |
| PRIMARY Cohort 3: AUC(0-t) of Digoxin in Plasma |
25353.1; 30842.3 | — |
| PRIMARY Cohort 3: AUC(0-infinity) of Digoxin in Plasma |
30743.6; 34456.5 | — |
| PRIMARY Cohort 3: Cmax of Midazolam in Plasma |
5.238; 6.507 | — |
| PRIMARY Cohort 3: Tlag of Midazolam in Plasma |
0.000; 0.000 | — |
| PRIMARY Cohort 3: Tmax of Midazolam in Plasma |
0.650; 0.500 | — |
| PRIMARY Cohort 3: AUC(0-t) of Midazolam in Plasma |
23.3; 44.8 | — |
| PRIMARY Cohort 3: AUC(0-infinity) of Midazolam in Plasma |
24.9; 47.4 | — |
| PRIMARY Cohort 4: Cmax of Gepotidacin Following Single Dose of 1500 mg in Plasma |
5.436; 5.143 | — |
| PRIMARY Cohort 4: Tmax of Gepotidacin Following Single Dose of 1500 mg in Plasma |
2.000; 1.500 | — |
| PRIMARY Cohort 4: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Concentration at 24 Hours Post-dose (AUC[0-24]) of Gepotidacin Following Single Dose of 1500 mg in Plasma |
20.9; 19.0 | — |
| PRIMARY Cohort 4: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Concentration at 48 Hours Post-dose (AUC[0-48]) of Gepotidacin Following Single Dose of 1500 mg in Plasma |
21.9; 20.0 | — |
| PRIMARY Cohort 4: AUC(0-t) of Gepotidacin Following Single Dose of 1500 mg in Plasma |
21.9; 20.0 | — |
| PRIMARY Cohort 4: AUC(0-infinity) of Gepotidacin Following Single Dose of 1500 mg in Plasma |
22.3; 20.4 | — |
| PRIMARY Cohort 4: Cmax of Gepotidacin in Plasma After the First Dose of 3000 mg -Fed State |
11.204 | — |
| PRIMARY Cohort 4: Tmax of Gepotidacin in Plasma After the First Dose of 3000 mg -Fed State |
2.000 | — |
| PRIMARY Cohort 4: AUC From Time 0 (Predose) to Time Tau (AUC[0-tau]) of Gepotidacin in Plasma After the First Dose of 3000 Mg-Fed State |
37.3 | — |
| PRIMARY Cohort 4: Cmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State |
12.363 | — |
| PRIMARY Cohort 4: Tmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State |
2.000 | — |
| PRIMARY Cohort 4: AUC(0-tau) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Evening Dose)-Fed State |
46.7 | — |
| PRIMARY Cohort 4: Accumulation Ratio Based on Cmax (RoCmax) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State |
1.103 | — |
| PRIMARY Cohort 4: Accumulation Ratio Based on AUC(0-tau) (RoAUC) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State |
1.254 | — |
| PRIMARY Cohort 4: AUC(0-24) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State |
84.6 | — |
| PRIMARY Cohort 4: AUC(0-48) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State |
90.8 | — |
| PRIMARY Cohort 4: AUC(0-t) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State |
91.4 | — |
| PRIMARY Cohort 4: Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE) |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline |
0; 0; 0; 0; 3; 11 | — |
| PRIMARY Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline |
0; 0; 0; 0; 3; 11 | — |
| PRIMARY Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline |
3; 11; 11; 11; 0; 0 | — |
| PRIMARY Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline |
0; 1; 0; 0; 3; 10 | — |
| PRIMARY Cohort 4: Number of Participants With Any Increase in Maximum Post-Baseline Electrocardiogram (ECG) Parameter Corrected QT (QTc) Interval |
1; 8; 3; 9; 1; 1 | — |
| PRIMARY Cohort 4: Cmax of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants |
5.421; 5.158 | — |
| PRIMARY Cohort 4: Tlag of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants |
0.000; 0.000 | — |
| PRIMARY Cohort 4: Tmax of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants |
2.000; 1.500 | — |
| PRIMARY Cohort 4: AUC(0-t) of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants |
21.9; 20.0 | — |
| PRIMARY Cohort 4: AUC(0-infinity) of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants |
22.3; 20.4 | — |
| SECONDARY Cohort 1: AUC (0-24) of Gepotidacin in Plasma |
19.3; 21.9 | — |
| SECONDARY Cohort 1: AUC(0-48) of Gepotidacin in Plasma |
20.3; 23.0 | — |
| SECONDARY Cohort 1: Tlag of Gepotidacin in Plasma |
0.000; 0.000 | — |
| SECONDARY Cohort 1: Apparent Volume of Distribution (Vz/F) of Gepotidacin in Plasma |
1190.16; 1143.29 | — |
| SECONDARY Cohort 1: Apparent Oral Clearance (CL/F) of Gepotidacin in Plasma |
72.72; 64.14 | — |
| SECONDARY Cohort 1: Total Unchanged Drug (Ae Total) of Gepotidacin in Urine |
337.92; 410.10 | — |
| SECONDARY Cohort 1: AUC(0-24) of Gepotidacin in Urine |
3292.1; 3612.4 | — |
| SECONDARY Cohort 1: AUC(0-48) of Gepotidacin in Urine |
3578.2; 3831.1 | — |
| SECONDARY Cohort 1: Renal Clearance (CLr) of Gepotidacin |
16.06; 17.59 | — |
| SECONDARY Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin |
28.66; NA; 89.18; 142.99; 50.52; 82.77 | — |
| SECONDARY Cohort 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin |
22.72; 26.90 | — |
| SECONDARY Cohort 1: Number of Participants With SAE and Non-SAE |
0; 0; 0; 0 | — |
| SECONDARY Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline |
0; 0; 14; 11; 0; 2 | — |
| SECONDARY Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline |
0; 0; 14; 11; 0; 2 | — |
| SECONDARY Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline |
14; 13; 0; 0; 14; 13 | — |
| SECONDARY Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline |
0; 0; 14; 13; 0; 0 | — |
| SECONDARY Cohort 1: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval |
3; 4; 0; 1 | — |
| SECONDARY Cohort 2: AUC(0-24) of Gepotidacin in Plasma |
17.9; 8.9 | — |
| SECONDARY Cohort 2: AUC(0-48) of Gepotidacin in Plasma |
19.0; 9.5 | — |
| SECONDARY Cohort 2: T1/2 of Gepotidacin in Plasma |
10.882; 10.972 | — |
| SECONDARY Cohort 2: Vz/F of Gepotidacin in Plasma |
1217.45; 2460.46 | — |
| SECONDARY Cohort 2: CL/F of Gepotidacin in Plasma |
77.55; 155.43 | — |
| SECONDARY Cohort 2: Ae Total of Gepotidacin in Urine |
312.73; 156.05 | — |
| SECONDARY Cohort 2: AUC(0-24) of Gepotidacin in Urine |
3081.3; 1352.4 | — |
| SECONDARY Cohort 2: AUC(0-48) of Gepotidacin in Urine |
3370.1; 1476.8 | — |
| SECONDARY Cohort 2: CLr of Gepotidacin |
16.49; 17.07 | — |
| SECONDARY Cohort 2: Ae(t1-t2) of Gepotidacin |
12.67; NA; 79.84; 55.81; 67.48; 21.66 | — |
| SECONDARY Cohort 2: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin |
20.85; 10.42 | — |
| SECONDARY Cohort 2: Number of Participants With SAE and Non-SAE |
0; 0; 0; 3; 2; 2 | — |
| SECONDARY Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline |
0; 0; 17; 16; 0; 1 | — |
| SECONDARY Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline |
0; 0; 17; 15; 0; 2 | — |
| SECONDARY Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline |
17; 16; 0; 0; 17; 16 | — |
| SECONDARY Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline |
0; 0; 16; 14; 1; 0 | — |
| SECONDARY Cohort 2: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval |
2; 2; 0; 1 | — |
| SECONDARY Cohort 3: Cmax of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose) |
7.867 | — |
| SECONDARY Cohort 3: Tmax of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose) |
2.500 | — |
| SECONDARY Cohort 3: Tlag of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose) |
0.250 | — |
| SECONDARY Cohort 3: AUC(0-tau) of Gepotidacin in Plasma First Dose of 3000 mg (First Dose) |
29.8 | — |
| SECONDARY Cohort 3: Cmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) |
10.051 | — |
| SECONDARY Cohort 3: Tmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) |
2.000 | — |
| SECONDARY Cohort 3: AUC(0-tau) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) |
41.9 | — |
| SECONDARY Cohort 3: RoCmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) |
1.278 | — |
| SECONDARY Cohort 3: RoAUC of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) |
1.406 | — |
| SECONDARY Cohort 3: AUC(0-24) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) |
73.2 | — |
| SECONDARY Cohort 3: AUC(0-48) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) |
81.2 | — |
| SECONDARY Cohort 3: AUC(0-t) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) |
85.2 | — |
| SECONDARY Cohort 3: Vz/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) |
959.42 | — |
| SECONDARY Cohort 3: CL/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) |
69.99 | — |
| SECONDARY Cohort 3: T1/2 of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose+ Second Dose) |
9.501 | — |
| SECONDARY Cohort 3: Minimum Observed Concentration (Cmin) of Digoxin in Plasma |
44.127; 77.447 | — |
| SECONDARY Cohort 3: T1/2 of Digoxin in Plasma |
39.367; 32.777 | — |
| SECONDARY Cohort 3: Vz/F of Digoxin in Plasma |
923.75; 688.49 | — |
| SECONDARY Cohort 3: CL/F of Digoxin in Plasma |
16.26; 14.51 | — |
| SECONDARY Cohort 3: Cmin of Midazolam in Plasma |
0.192; 0.222 | — |
| SECONDARY Cohort 3: T1/2 of Midazolam in Plasma |
5.320; 6.075 | — |
| SECONDARY Cohort 3: Vz/F of Midazolam in Plasma |
615.36; 371.24 | — |
| SECONDARY Cohort 3: CL/F of Midazolam in Plasma |
80.17; 42.16 | — |
| SECONDARY Cohort 3: Ae Total of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose ) |
1066.21 | — |
| SECONDARY Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) |
NA; 117.61; 103.11; 70.98; 67.42; 64.49 | — |
| SECONDARY Cohort 3: AUC(0-tau) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose) |
4770.8 | — |
| SECONDARY Cohort 3: AUC(0-24) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose) |
14333.9 | — |
| SECONDARY Cohort 3: AUC (0-48) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose) |
16682.1 | — |
| SECONDARY Cohort 3: Percentage of the Given Dose of Drug Excreted in Urine (fe%) Following Two 3000 mg Doses of Gepotidacin (First Dose + Second Dose ) |
17.77 | — |
| SECONDARY Cohort 3: CLr of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) |
13.19 | — |
| SECONDARY Cohort 3: Number of Participants With SAE and Non-SAE |
0; 0; 1; 11 | — |
| SECONDARY Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline |
0; 0; 19; 18; 0; 0 | — |
| SECONDARY Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline |
0; 0; 19; 17; 0; 1 | — |
| SECONDARY Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline |
19; 18; 0; 0; 19; 18 | — |
| SECONDARY Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline |
0; 0; 19; 18; 0; 0 | — |
| SECONDARY Cohort 3: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval |
2; 5; 0; 0 | — |
| SECONDARY Cohort 4: T1/2 of Gepotidacin Following Single Dose of 1500 mg in Plasma |
12.848; 12.540 | — |
| SECONDARY Cohort 4: Vz/F of Gepotidacin Following Single Dose of 1500 mg in Plasma |
1246.70; 1329.83 | — |
| SECONDARY Cohort 4: CL/F of Gepotidacin Following Single Dose of 1500 mg in Plasma |
67.26; 73.50 | — |
| SECONDARY Cohort 4: Tlag of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose)-Fed State |
— | — |
| SECONDARY Cohort 4: Vz/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State |
1251.05 | — |
| SECONDARY Cohort 4: CL/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State |
68.83 | — |
| SECONDARY Cohort 4: T1/2 of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose )-Fed State |
12.599 | — |
| SECONDARY Cohort 4: Ae Total of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine |
293.50 | — |
| SECONDARY Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine |
NA; 102.23; 60.05; 31.61; 16.51; 17.16 | — |
| SECONDARY Cohort 4: AUC(0-24) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine |
2142.4 | — |
| SECONDARY Cohort 4: AUC(0-48) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine |
2293.7 | — |
| SECONDARY Cohort 4: Percentage of the Given Dose of Drug Excreted in Urine (fe%) for Gepotidacin 1500 mg Under Fed Condition |
19.57 | — |
| SECONDARY Cohort 4: CLr of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition |
13.42 | — |
| SECONDARY Cohort 4: Ae Total of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State |
1334.42 | — |
| SECONDARY Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State |
NA; 221.19; 103.68; 67.58; 65.06; 112.83 | — |
| SECONDARY Cohort 4: AUC(0-tau) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State |
4996.9 | — |
| SECONDARY Cohort 4: AUC(0-24) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State |
14729.5 | — |
| SECONDARY Cohort 4: AUC(0-48) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State |
15768.2 | — |
| SECONDARY Cohort 4: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin Following Two 3000 mg Doses-Fed State |
22.24 | — |
| SECONDARY Cohort 4: CLr of Gepotidacin Following Two 3000 mg Dose-Fed State |
14.61 | — |
Summary
This study is a drug-drug interaction (DDI), pharmacokinetics (PK), safety and tolerability study in adult healthy participants, including Japanese cohort. This study is designed to assess co-administration of probe substrates with gepotidacin in study cohorts 1 to 3 and establishing PK and safety in Japanese participants in cohort 4. Food effect will also be evaluated in cohort 4.
Eligibility Criteria
Inclusion Criteria
- Participant must be greater than or equal to (>=) 18 to less than or equal to (= =40 kilograms (kg) and body mass index within the range 18.5 to 32.0 kilograms per square meter (kg/m^2) (inclusive).
- Male and/or female: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies: Is a woman of non-childbearing potential or Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of 450 milliseconds (msec) at Screening or Check-in.
- Presence of hepatitis B surface antigen or positive hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention.
- Alanine aminotransferase (ALT) >1.5 times upper limit of normal (ULN) at Screening or Check-in.
- Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin 21 units (or an average daily intake of >3 units) for males or an average weekly intake of >14 units (or an average daily intake >2 units) for females. One unit is equivalent to 270 mL of full strength beer, 470 mL of light beer, 30 mL of spirits, or 100 mL of wine.
- Cohort 3 Only: Digoxin-related exclusions include the following at Screening:
Serum potassium >5.5 milliequivalent per liter (mEq/L) or < 3.6 mEq/L Serum magnesium <1.6 milligrams per deciliter (mg/dL) Serum calcium (total) <8.5 mg/dL History of hypersensitivity to digoxin or other digitalis glycosides Any clinically relevant abnormality on 12-lead ECG at Screening or Check-in.
- Participant has donated blood in excess of 500 mL within 12 weeks prior to dosing or participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day period.
- Participant is unable to comply with all study procedures, in the opinion of the investigator.
- Participant should not participate in the study, in the opinion of the investigator or Sponsor.
Data sourced from ClinicalTrials.gov (NCT04493931). 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.