A Study to Evaluate Safety, Tolerability and Pharmacokinetics of GSK2556286 in Healthy Adult Participants

Summary

This first time in human (FTIH) study assesses the safety, tolerability, and pharmacokinetics (PK) of single and multiple increasing doses of GSK2556286. It also includes food effect cohorts to evaluate how food influences the PK of GSK2556286. The findings will help determine appropriate dosing for future clinical studies.

Timeline

Start

2020-10-30

Primary completion

2024-11-06

Completion

2024-11-06

Outcome

Outcome not reported

Stopped: “A decision to stop the study was made by the site and GSK project team based on pre-defined stopping criteria in the protocol”

Publications

• Ilsley E, Banham-Hall E, Chaychenko T, Chinenyeze K, Maher-Edwards G, Muya C, Rolfe K, Sharma R, Tiberi S, Barros-Aguirre D. Randomized, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Oral Doses of Novel Antitubercular Drug Candidate, GSK2556286, in Healthy Adults. J Clin Pharmacol. 2026 May;66(5):e70203. doi: 10.1002/jcph.70203.
• Nuermberger EL, Martinez-Martinez MS, Sanz O, Urones B, Esquivias J, Soni H, Tasneen R, Tyagi S, Li SY, Converse PJ, Boshoff HI, Robertson GT, Besra GS, Abrahams KA, Upton AM, Mdluli K, Boyle GW, Turner S, Fotouhi N, Cammack NC, Siles JM, Alonso M, Escribano J, Lelievre J, Rullas-Trincado J, Perez-Herran E, Bates RH, Maher-Edwards G, Barros D, Ballell L, Jimenez E. GSK2556286 Is a Novel Antitubercular Drug Candidate Effective In Vivo with the Potential To Shorten Tuberculosis Treatment. Antimicrob Agents Chemother. 2022 Jun 21;66(6):e0013222. doi: 10.1128/aac.00132-22. Epub 2022 May 24.

Drugs

Indications