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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
12
Participants will receive single oral dose of Peposertib tablet under fasting (Treatment A) or fed (Treatment B) conditions.
Participants will receive oral suspension dose of peposertib tablets under fasted condition (Treatment C) in either period 1, 2 or 3 of part 1.
Nuvisan GmbH
Gauting, Germany
Nuvisan GmbH
Neu-Ulm, Germany
Part 1 and Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Sampling (AUC0-tlast) of Peposertib
Time frame: Pre-dose up to 36 hours post-dose
Part 1 and Part 2: Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC-inf) of Peposertib
Time frame: Pre-dose up to 36 hours post-dose
Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) of Peposertib
Time frame: Pre-dose up to 36 hours post-dose
Part 1 and Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Part 1: up to 21 days; Part 2: up to 14 days
Part 1 and Part 2: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) Based on Severity According to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Time frame: Part 1: up to 21 days; Part 2: up to 14 days
Part 1 and Part 2: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Findings
Number of participants with clinically significant change from baseline in laboratory parameters, vital signs and 12-Lead electrocardiogram (ECG) findings will be reported.
Time frame: Part 1: up to 21 days; Part 2: up to 14 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.