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Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid

NCT04309656 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-07-24

Study results available
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Summary

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

Conditions

  • Multi-drug Resistant Tuberculosis

Interventions

DRUG

Pretomanid

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.

Sponsors & Collaborators

  • Global Alliance for TB Drug Development

    lead OTHER

Principal Investigators

  • Antonio Lombardi, MD · TB Alliance

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2020-02-28
Completion
2020-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04309656 on ClinicalTrials.gov