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

Summary

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

Timeline

Start

2020-01-14

Primary completion

2020-02-28

Completion

2020-02-28

Outcome

Met primary endpoint

registry Geometric mean ratio (%) 85.85 (90% CI 81.21 to 90.75) NCT04309656 ↗

registry Geometric mean ratio (%) 92.99 (90% CI 82.65 to 104.62) NCT04309656 ↗

registry Geometric mean ratio (%) 100.60 (90% CI 98.23 to 103.03) NCT04309656 ↗

registry Geometric mean ratio (%) 89.70 (90% CI 81.20 to 99.10) NCT04309656 ↗

registry Geometric mean ratio (%) 101.03 (90% CI 98.65 to 103.47) NCT04309656 ↗

registry Geometric mean ratio (%) 89.63 (90% CI 81.10 to 99.05) NCT04309656 ↗

Publications

• Zou Y, Nedelman J, Lombardi A, Pappas F, Karlsson MO, Svensson EM. Characterizing Absorption Properties of Dispersible Pretomanid Tablets Using Population Pharmacokinetic Modelling. Clin Pharmacokinet. 2022 Nov;61(11):1585-1593. doi: 10.1007/s40262-022-01163-w. Epub 2022 Sep 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pretomanid	Small molecule	10 mg	Oral
Subject	Pretomanid	Small molecule	50 mg	Oral
Subject	Pretomanid	Small molecule	200 mg	Oral

Indications