Effect of Food on Peposertib PK

Phase 1 Completed 12 enrolled Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

RandomizedCrossoverOpen-labelOther

Summary

The study will investigate the effect of food on the Pharmacokinetic (PK) of a single dose of peposertib administered as film-coated tablet under fed and fasted conditions. Furthermore, the PK profile of peposertib administered as an oral suspension of disintegrated tablets and as film-coated tablets will be compared under fasted conditions to evaluate the relative bioavailability in healthy participants.

Timeline

Start: 2021-01-14
Primary completion: 2021-03-03
Completion: 2021-03-03

Publications

Becker A, Krebs-Brown A, Vetter C, Reuter T, Rodriguez-Gutierrez A, You X, Lissy M. Phase I crossover study of DNA-protein kinase inhibitor peposertib in healthy volunteers: Effect of food and pharmacokinetics of an oral suspension. Clin Transl Sci. 2023 Dec;16(12):2628-2639. doi: 10.1111/cts.13657. Epub 2023 Oct 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NEDISERTIB	Small molecule	100 mg	Oral

Indications

No indication recorded.