Trial Profile

A Phase 1, Open-label, Randomized, Crossover Study to Assess the Drug-Drug Interaction Between Bedaquiline and Clarithromycin in Healthy Adult Volunteers

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 24 May 2021

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At a glance

Drugs Bedaquiline (Primary) ; Clarithromycin (Primary)
Indications Leprosy; Mycobacterium avium complex infections; Nontuberculous mycobacterium infections; Tuberculosis
Focus Pharmacokinetics
Sponsors Janssen Research & Development

Most Recent Events

15 May 2021 Results assessing the steady-state of bedaquiline PK under various dosing regimens to choose the ideal optimal dose regimen of bedaquiline in combination with clarithromycin for PNTM diseases, published in the Journal of Clinical Pharmacology.
26 Aug 2019 Status changed from recruiting to completed.
28 Mar 2019 Status changed from not yet recruiting to recruiting.

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