The objective of this study is to determine the magnitude and clinical relevance of a potential drug-drug interaction of GSK3882347 with midazolam (MDZ) in healthy participants. This study assesses the effect of GSK3882347 as an inducer of Cytochrome P450 3A4 (CYP3A4) using MDZ, a sensitive substrate of hepatic and intestinal CYP3A4. The study will investigate MDZ pharmacokinetic (PK) effect in two dosing periods: Period 1: A single dose of MDZ Period 2: 14-days of once daily repeat dosing of GSK3882347 followed by single dose of MDZ co-administered with GSK3882347 on Day 15 (14-days has been selected as this duration is required in order to maximize any potential CYP3A4 enzyme induction).
Age range
18 Years – 65 Years
Sex
ALL
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Period 1: Area under the curve from time zero to 24 hours (AUC [0-24]) for plasma concentration of MDZ
Timeframe: Up to 24 hours
Period 1: AUC (0-24) for plasma concentration of 1-hydroxy-MDZ
Timeframe: Up to 24 hours
Period 2: AUC (0-24) for plasma concentration of MDZ
Timeframe: Up to 24 hours
Period 2: AUC (0-24) for plasma concentration of 1-hydroxy-MDZ
Timeframe: Up to 24 hours
Period 1: AUC from time zero to last time of quantifiable concentration (AUC [0-tau]) for plasma concentration of MDZ
Timeframe: Up to Day 2
Period 1: AUC (0-tau) for plasma concentration of 1-hydroxy-MDZ
Timeframe: Up to Day 2
Period 2: AUC (0-tau) for plasma concentration of MDZ
Timeframe: Up to Day 15
Period 2: AUC (0-tau) for plasma concentration of 1-hydroxy-MDZ
Timeframe: Up to Day 15
Period 1: AUC from time zero extrapolated to infinite time (AUC [0-inf]) for plasma concentration of MDZ
Timeframe: Up to Day 2
Period 1: AUC (0-inf) for plasma concentration of 1-hydroxy-MDZ
Timeframe: Up to Day 2
Period 2: AUC (0-inf) for plasma concentration of MDZ
Timeframe: Up to Day 15
Period 2: AUC (0-inf) for plasma concentration of 1-hydroxy-MDZ
Timeframe: Up to Day 15
Period 1: Maximum plasma concentration (Cmax) of MDZ
Timeframe: Up to Day 2
Period 1: Cmax of 1-hydroxy-MDZ
Timeframe: Up to Day 2
Period 2: Cmax of MDZ
Timeframe: Up to Day 15
Period 2: Cmax of 1-hydroxy-MDZ
Timeframe: Up to Day 15
Period 1: Time to Cmax (Tmax) of MDZ
Timeframe: Up to Day 2
Period 1: Tmax of 1-hydroxy-MDZ
Timeframe: Up to Day 2
Period 2: Tmax of MDZ
Timeframe: Up to Day 15
Period 2: Tmax of 1-hydroxy-MDZ
Timeframe: Up to Day 15
Period 1: Time lag before observation of measurable concentrations (Tlag) of MDZ
Timeframe: Up to Day 2
Period 1: Tlag of 1-hydroxy-MDZ
Timeframe: Up to Day 2
Period 2: Tlag of MDZ
Timeframe: Up to Day 15
Period 2: Tlag of 1-hydroxy-MDZ
Timeframe: Up to Day 15
Period 1: Time to half-life (T1/2) of MDZ
Timeframe: Up to Day 2
Period 1: T1/2 of 1-hydroxy-MDZ
Timeframe: Up to Day 2
Period 2: T1/2 of MDZ
Timeframe: Up to Day 15
Period 2: T1/2 of 1-hydroxy-MDZ
Timeframe: Up to Day 15