NCT05760261

Drug Interaction Assessment of GSK3882347 in Healthy Participants Aged 18 to 65 Years

A Phase 1, Open-Label Study in Healthy Participants Aged 18 to 65 Years to Investigate the CYP3A4 Induction Potential of GSK3882347

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Midazolam	Midazolam will be administered.
DRUG	GSK3882347	GSK3882347 will be administered.

Timeline

• Start date: 2023-04-11
• Primary completion: 2024-08-13
• Completion: 2024-08-20
• First posted: 2023-03-08
• Last updated: 2025-01-16

Locations

1 site across 1 country: United Kingdom