CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
TBAJ-876 +2 moredrug
Likely dose
TBAJ-876 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05526911
NCT05526911Phase 1Completed
CompareCT.gov

A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects

Global Alliance for TB Drug Development·interventional·Posted Sep 2, 2022·Updated Oct 8, 2024

In Brief

A Phase 1 clinical trial evaluating TBAJ-876, Midazolam, and 1 other intervention for Pulmonary Disease and 6 related conditions. Completed, enrolled 28 participants across 1 site.

Detailed Summary

A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis, Drug Sensitive Tuberculosis, Drug-resistant Tuberculosis, Mycobacterium Tuberculosis Infection
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedSep 2, 2022
Enrollment StartJun 30, 2022
Primary CompletionSep 26, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 3.8 years ago

Interventions

TBAJ-876drug

* Day 6 to Day 13: 200 mg TBAJ-876 oral suspension, fed * Day 14 to Day 19: 165 mg TBAJ-876 oral suspension, fed * Day 20 and Day 21: 200 mg TBAJ-876 oral suspension, fasting * Day 22 to Day 24: 150 mg TBAJ-876 oral suspension, fed

Midazolamdrug

Day 1 and Day 20: Midazolam oral syrup: 2 mg, fasted

Digoxindrug

Day 2 and Day 21: Digoxin tablet: 0.25 mg, fasted