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NCT03896750 · ClinicalTrials.gov registry record · Phase 1
Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function
A Phase 1 study of Renal Impairment and Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 3
- Study locations
NCT03896750 is a Phase 1 study of Renal Impairment and Tuberculosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 12 participants, below the 34-participant average among 32 other Renal Impairment trials with a reported enrollment target (65% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT03896750, a Phase 1 study of Renal Impairment and Tuberculosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a Phase 1, open-label, single-dose, sequential group study to compare the safety and pharmacokinetics (PK) of pretomanid in the following groups of participants: 1) participants with severe renal impairment including those with end stage renal disease (ESRD) not on dialysis, and participants with mild or moderate renal impairment, designated as Groups 2, 3, and 4, respectively; and 2) participants with normal renal function matched to the above renal impairment groups, designated as Groups 1A, 1B, and 1C, respectively. The study will be conducted following a reduced PK study design in Part A. Part A will enroll participants from Group 1A (i.e., 6 healthy matched controls) and Group 2 (i.e., 6 participants with severe renal impairment and ESRD, not on dialysis). A decision to proceed to Part B will be made after the PK of pretomanid, and safety in participants enrolled in Part A have been reviewed. If Part A demonstrates at least a 50% increase in pretomanid area under the plasma concentration-time curve (AUC) in Group 2 (severe renal impairments and ESRD, not on dialysis) relative to the exposures in Group 1A (matched participants with normal renal function), then the reduced PK study will extend to the full PK study to enroll participants into Part B (i.e., to investigate mild and moderate renal impairment). All Part B groups (1B, 1C, 3, and 4) will be enrolled concurrently. If the reduced PK study shows at least a 50% increase in AUC in patients with severe renal impairment and patients with ESRD not yet on dialysis relative to the matched healthy controls, a "full PK" renal impairment study in patients with all intermediate levels of renal function impairment should be conducted. Otherwise, no further study is recommended. The approximate patient involvement will be 3 months. The primary objective is to evaluate the PK profiles of pretomanid in plasma and urine after a single oral dose of 200 mg in participants with renal impairment compared to matched
Conditions Studied
Interventions
- DRUG PA-824
Study Locations (3)
Florida
- Advanced Pharma - Miami - Miami
Missouri
- Saint Louis University Center for Vaccine Development - St Louis
Tennessee
- Alliance for Multispecialty Research, LLC - Knoxville - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-04-17 |
| Est. Completion | 2024-10-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03896750
The ClinicalTrials.gov registry entry for NCT03896750 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 34-participant average among 32 other Renal Impairment trials with a reported enrollment target (65% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Renal Impairment appearing as the primary indexed condition, and to 1 intervention - of which PA-824 is the first listed.
NCT03896750 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Florida, Missouri, Tennessee.
Frequently Asked Questions
What is clinical trial NCT03896750 about?
NCT03896750 is a clinical study titled "Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function". This is a Phase 1, open-label, single-dose, sequential group study to compare the safety and pharmacokinetics (PK) of pretomanid in the following groups of participants: 1) participants with severe renal impairment including those with end stage renal disease (ESRD) not on dialysis, and participants...
What is the current status of trial NCT03896750?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2024-04-17. Estimated completion is 2024-10-28.
What conditions does trial NCT03896750 study?
This clinical trial studies the following conditions: Renal Impairment, Tuberculosis.
What interventions are being tested in trial NCT03896750?
The interventions under investigation include: PA-824 (DRUG).
Who is sponsoring clinical trial NCT03896750?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03896750 being conducted?
This trial has 3 study locations across Florida, Missouri, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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