Status:
COMPLETED
Effect of Food on Peposertib PK
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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 exclusion criteria could apply
Key Trial Info
Start Date :
January 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04702698
Start Date
January 14 2021
End Date
March 3 2021
Last Update
May 12 2021
Active Locations (2)
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1
Nuvisan GmbH
Gauting, Germany
2
Nuvisan GmbH
Neu-Ulm, Germany