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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
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
GSK3036656
GSK3036656 was administered.
Bedaquiline
Bedaquiline was administered.
Delamanid
Delamanid was administered.
RIFAFOUR e-275
RIFAFOUR e-275 was administered.
BTZ-043
BTZ-043 was administered.
Pretomanid
Pretomanid was administered.
Linezolid
Linezolid was administered.
Moxifloxacin
Moxifloxacin was administered.
Locations (1)
GSK Investigational Site
Bellville, South Africa