At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating GSK3915393 Capsules, GSK3915393 Solution for Infusion, and 4 other interventions for Celiac Disease and Coeliac Disease. Completed, enrolled 65 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
GSK3915393 capsules will be given orally.
GSK3915393 solution for infusion will be administered intravenously.
Placebo matching GSK3915393 capsules will be given orally.
Participants will be administered with GSK3915393 along with ITZ orally
Participants will be administered with GSK3915393 along with water orally
Participants will be administered with GSK3915393 along with GFJ orally