CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
Pretomaniddrug
Likely dose
Pretomanid 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/NCT04309656
NCT04309656Phase 1Completed
CompareCT.gov

An Open-label, Randomized, Four-period, Crossover Study in Two Panels of Healthy Adult Subjects to Assess the Relative Bioavailability, Food Effect, and Dose-dependence of Single-dose Immediate-release and Single-dose Dispersible Formulations of Pretomanid

Global Alliance for TB Drug Development·interventional·Posted Mar 16, 2020·Updated Jul 24, 2024

In Brief

A Phase 1 clinical trial evaluating Pretomanid for Multi-drug Resistant Tuberculosis. Completed, enrolled 48 participants across 1 site.

Detailed Summary

This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMulti-drug Resistant Tuberculosis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedMar 16, 2020
Enrollment StartJan 14, 2020
Primary CompletionFeb 28, 2020
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 6.3 years ago

Interventions

Pretomaniddrug

1. Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2. Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3. Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4. Treatment D (test) = single 10-mg dispersible tablet, orally administered.