NCT04702698

Effect of Food on Peposertib PK

Phase I, Open-Label, Randomized, Single-Dose Study With Crossover Design to Investigate the Effect of Food on the PK of Peposertib Tablet Formulation and to Investigate the PK of Peposertib Administered as Oral Suspension of Disintegrated Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Peposertib	Participants will receive single oral dose of Peposertib tablet under fasting (Treatment A) or fed (Treatment B) conditions.
DRUG	Peposertib	Participants will receive oral suspension dose of peposertib tablets under fasted condition (Treatment C) in either period 1, 2 or 3 of part 1.

Timeline

• Start date: 2021-01-14
• Primary completion: 2021-03-03
• Completion: 2021-03-03
• First posted: 2021-01-11
• Last updated: 2021-05-12

Locations

2 sites across 1 country: Germany