Single-Dose Study to Evaluate the PKs of Pretomanid in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

Summary

Participation Requirements

Description

This is a Phase I, open-label, single dose, sequential group study to compare the safety and pharmacokinetics of pretomanid in the following two groups of subjects: 1) those with mild, moderate, and severe renal impairment including those with End Stage Renal Disease (ESRD) not needing dialysis; and...

This is a Phase I, open-label, single dose, sequential group study to compare the safety and pharmacokinetics of pretomanid in the following two groups of subjects: 1) those with mild, moderate, and severe renal impairment including those with End Stage Renal Disease (ESRD) not needing dialysis; and 2) matched subjects with normal renal function. The study will be conducted in two parts. Part A will enroll subjects from Groups 1A and 2 (i.e. 6 healthy matched controls and 6 subjects with ESRD, not on dialysis). A decision to enroll subjects into Part B (i.e. to investigate mild, moderate and severe renal impairment) will be conducted after the pharmacokinetics (PK) of the parent compound and safety of subjects enrolled in Part A have been reviewed. Part B will be conducted if the results of Part A demonstrate that patients with ESRD, not on dialysis have different exposures to pretomanid that may impact safety or efficacy relative to the exposures of healthy subjects. If the decision is taken to conduct Part B, 6 subjects each with mild, moderate and severe renal impairment (Groups 3, 4, 5) will be enrolled together with additional healthy matched subjects (Groups 1B-1D). Part B, treatment Groups 3, 4, and 5 will be initiated concurrently when each subject in Groups 1A and 2 has completed Part A of the study. The approximate patient involvement will be 3 months. The primary objective is to evaluate the PK of pretomanid after a single oral dose of 200 mg in subjects with renal impairment compared to matched healthy controls. The secondary objectives are 1) to assess the safety profile of a single oral dose of 200 mg pretomanid in renally impaired subjects to matched healthy controls; and 2) to measure representative plasma pretomanid metabolites (M19 and M50) for analysis.

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