NCT04604795

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GSK3915393 in Healthy Participants and to Evaluate the Interaction Between GSK3915393 and Grapefruit Juice and Itraconazole

A Randomized, Placebo Controlled, Double Blind, Single and Repeat Dose Escalation Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of GSK3915393 in Healthy Participants and Open Label Assessment of Coadministration of GSK3915393 With Grapefruit Juice and Itraconazole on the Pharmacokinetics of GSK3915393

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a 3-part first time into human study (FTIH) study for GSK3915393. Parts A and B of the study will evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending and repeat oral doses of GSK3915393 in healthy adult participants. Part C will evaluate the impact of co-administration of GSK3915393 with grapefruit juice and itraconazole on the PK of GSK3915393.

Conditions

• Celiac Disease
• Coeliac Disease

Interventions

Type	Name	Description
DRUG	GSK3915393 Capsules	GSK3915393 capsules will be given orally.
DRUG	GSK3915393 Solution for Infusion	GSK3915393 solution for infusion will be administered intravenously.
DRUG	Placebo capsules	Placebo matching GSK3915393 capsules will be given orally.
DRUG	Itraconazole	Participants will be administered with GSK3915393 along with ITZ orally
OTHER	Water	Participants will be administered with GSK3915393 along with water orally
OTHER	Grape fruit juice	Participants will be administered with GSK3915393 along with GFJ orally

Timeline

• Start date: 2020-11-04
• Primary completion: 2021-06-29
• Completion: 2021-06-29
• First posted: 2020-10-27
• Last updated: 2023-05-09
• Results posted: 2023-05-09

Locations

1 site across 1 country: United Kingdom