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drugset / Trial / NCT05473195

A Phase 2 Trial to Evaluate the EBA, Safety and Tolerability of Eto Alone and in Combination With BVL-GSK098

NCT05473195 ↗

Phase 2 Completed 105 enrolled TASK Applied Science GlaxoSmithKline · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the 7-day early bactericidal activity (EBA), pharmacokinetics (PK), safety and tolerability of ethionamide (Eto) with or without BVL-GSK098 in participants with rifampicin- and isoniazid-susceptible pulmonary TB.

Timeline

Start
2022-12-06
Primary completion
2024-04-16
Completion
2024-04-16

Drugs

EvaluationDrugModalityDoseRoute
Subject BVL-GSK098 Unknown 9 mg Oral
Subject BVL-GSK098 Unknown 27 mg Oral
Subject Ethionamide Small molecule 125 mg Oral
Subject Ethionamide Small molecule 250 mg Oral
Subject Ethionamide Small molecule 500 mg Oral
Subject Ethionamide Small molecule 750 mg Oral
Comparator Isoniazid Small molecule 300 mg Oral

Indications

primary pulmonary tuberculosis