Healthy
Conditions
Keywords
Peposertib, Pharmacokinetics, Relative Bioavailability
Brief 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.
Interventions
DRUGPeposertib
Participants will receive single oral dose of Peposertib tablet under fasting (Treatment A) or fed (Treatment B) conditions.
Sponsors
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring * Participants are nonsmoker for at least 6 months prior to Screening * Participants have a body weight greater than 50 kilogram (kg) and a body mass index within the range 18.5 to 30.0 kilogram per meter square (inclusive) at Screening * Male participants are refrain from donating sperm plus either abstain from any activity that allows for exposure to ejaculate * Female participants are not pregnant or breastfeeding * Other protocol defined inclusion criteria could apply
Exclusion criteria
* History of clinically relevant renal, cardiovascular, pulmonary disease, or endocrinology disorder at Screening * History of clinically relevant gastrointestinal disease, in particular pancreatic disease, cholecystitis, liver diseases or hepatic dysfunction at Screening * History of psychiatric or relevant neurological disorders (example, depression, epilepsy) at Screening * History of relevant skin and mucosal diseases (rash, mucositis) at Screening * Presence or history of any serious allergy (requiring hospitalization or prolonged systemic treatment) at Screening * Any planned radiologic assessments during the study conduct phase * Participants who are not able or willing to eat the entire study meals. * Other protocol defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 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 | Pre-dose up to 36 hours post-dose |
| Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) of Peposertib | Pre-dose up to 36 hours post-dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 and Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | 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 | 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 | Part 1: up to 21 days; Part 2: up to 14 days | Number of participants with clinically significant change from baseline in laboratory parameters, vital signs and 12-Lead electrocardiogram (ECG) findings will be reported. |
Countries
Germany
Outcome results
None listed