Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BVL-GSK098 in Healthy Volunteers

Phase 1 Completed 80 enrolled BioVersys AG

RandomizedSequentialQuadruple-blindTreatment

Summary

This is a phase I single-center, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics and food effect of BVL-GSK098 administered as single and multiple oral doses to healthy volunteers

Timeline

Start: 2020-12-02
Primary completion: 2022-05-30
Completion: 2023-01-16

Publications

Pieren M, Abaigar Gutierrez-Solana A, Antonijoan Arbos RM, Boyle GW, Davila M, Davy M, Gitzinger M, Husband L, Martinez-Martinez MS, Mazarro DO, Pefani E, Penman SL, Remuinan MJ, Vlasakakis G, Zeitlinger M, Dale GE. First-in-human study of alpibectir (BVL-GSK098), a novel potent anti-TB drug. J Antimicrob Chemother. 2024 Jun 3;79(6):1353-1361. doi: 10.1093/jac/dkae107.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BVL-GSK098	Unknown	0.5 mg	Oral
Subject	BVL-GSK098	Unknown	5 mg	Oral
Subject	BVL-GSK098	Unknown	10 mg	Oral
Subject	BVL-GSK098	Unknown	30 mg	Oral
Subject	BVL-GSK098	Unknown	40 mg	Oral

Indications

No indication recorded.