Clinical trial NCT04702698: Effect of Food on Peposertib PK
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Peposertib
Pharmacokinetics
Relative Bioavailability
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Pre-dose up to 36 hours post-dose
measure: Part 1 and Part 2: Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC-inf) of Peposertib
timeFrame: Pre-dose up to 36 hours post-dose
measure: Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) of Peposertib
timeFrame: Pre-dose up to 36 hours post-dose
Secondary outcomes:
measure: Part 1 and Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: Part 1: up to 21 days; Part 2: up to 14 days
measure: 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
timeFrame: Part 1: up to 21 days; Part 2: up to 14 days
measure: 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
timeFrame: Part 1: up to 21 days; Part 2: up to 14 days
Other outcomes:
Locations:
city: Gauting
country: Germany
facility: Nuvisan GmbH
city: Neu-Ulm
country: Germany
facility: Nuvisan GmbH
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: