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COMPLETED
NCT05382312
PHASE2

Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study measured the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of GSK3036656 in combination with either delamanid, bedaquiline or BTZ-043 and delamanid in combination with bedaquiline or standard of care, for 14 days, in participants with newly diagnosed sputum smear positive drug-sensitive pulmonary tuberculosis. Participants reverted to the standard treatment (RIFAFOUR e-275) once the study treatment (Day 1 to Day 14) was completed.

Official title: A Parallel Group, Phase 2A, Randomised, Open Label Treatment Study to Assess the Early Bactericidal Activity, Safety and Tolerability of GSK3036656 Administered as a Two Drug Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin-susceptible Pulmonary Tuberculosis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

127

Start Date

2022-07-26

Completion Date

2025-05-27

Last Updated

2026-06-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

GSK3036656

GSK3036656 was administered.

DRUG

Bedaquiline

Bedaquiline was administered.

DRUG

Delamanid

Delamanid was administered.

DRUG

RIFAFOUR e-275

RIFAFOUR e-275 was administered.

DRUG

BTZ-043

BTZ-043 was administered.

DRUG

Pretomanid

Pretomanid was administered.

DRUG

Linezolid

Linezolid was administered.

DRUG

Moxifloxacin

Moxifloxacin was administered.

Locations (1)

GSK Investigational Site

Bellville, South Africa