Healthy Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | March 3, 2021 |
Est. primary completion date | March 3, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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 exclusion criteria could apply |
Country | Name | City | State |
---|---|---|---|
Germany | Nuvisan GmbH | Gauting | |
Germany | Nuvisan GmbH | Neu-Ulm |
Lead Sponsor | Collaborator |
---|---|
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | 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 | ||
Primary | Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) of Peposertib | Pre-dose up to 36 hours post-dose | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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. | Part 1: up to 21 days; Part 2: up to 14 days |
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