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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

NCT04604795 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-05-09

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2021-06-29
Completion
2021-06-29

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04604795 on ClinicalTrials.gov