NCT04488770

Safety, Tolerability and Pharmacokinetic Investigation of GSK3882347 in Healthy Participants.

A Double-Blind Randomized, Placebo-Controlled, Single and Repeated Oral Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Effect) of GSK3882347 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, first time in human (FTIH) study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and pharmacokinetics (PK) of GSK3882347 in healthy adult men and Woman of Non Childbearing Potential (WONCBP). Part 1 will be the single ascending dose (SAD) phase and Part 2 will be the multiple ascending dose (MAD) phase. Each participant in the SAD cohort will receive a single dose of GSK3882347 or placebo (PBO) in 3:1 ratio and in Part 2 (MAD), participants will be randomized in a 4:1 ratio to receive active treatment and placebo. Part 1 will consist of two cohorts with a maximum of four-period for each cohort, the food effect evaluation will be conducted in last period (Period 4) in only one of the cohorts based on the observed human pharmacokinetics (PK). Part 2 will consist of maximum of four cohorts for each of the MAD dose or placebo.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	GSK3882347	Capsule of 10-200mg dose strength will be provided in labelled High Density Polyethylene (HDPE) bottles.
DRUG	Placebo	Matching strength placebo capsules will be provided

Timeline

• Start date: 2020-08-24
• Primary completion: 2021-05-14
• Completion: 2021-05-14
• First posted: 2020-07-28
• Last updated: 2023-02-17
• Results posted: 2023-02-17

Locations

1 site across 1 country: United Kingdom