drugset

drugset / Trial / NCT01341184

TMC207 +/- Rifabutin/Rifampin

NCT01341184 ↗

Phase 1 Completed 33 enrolled National Institute of Allergy and Infectious Diseases (NIAID)

RandomizedParallel-groupOpen-labelTreatment

Summary

Evaluation of effect of rifampin or rifabutin on single dose PK of TMC207 in healthy volunteers

Timeline

Start: 2011-10-21
Primary completion: 2012-05-23
Completion: 2012-05-23

Publications

Healan AM, Griffiss JM, Proskin HM, O'Riordan MA, Gray WA, Salata RA, Blumer JL. Impact of Rifabutin or Rifampin on Bedaquiline Safety, Tolerability, and Pharmacokinetics Assessed in a Randomized Clinical Trial with Healthy Adult Volunteers. Antimicrob Agents Chemother. 2017 Dec 21;62(1):e00855-17. doi: 10.1128/AAC.00855-17. Print 2018 Jan.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bedaquiline	Small molecule	400 mg	Oral
Subject	Rifabutin	Small molecule	300 mg	Oral
Subject	Rifampin	Small molecule	600 mg	Oral

Indications