Effect of Food on Peposertib PK

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04702698
• Other study ID #: MS100036_0040
• Secondary ID: 2020-004187-26
• Status: Completed
• Phase: Phase 1
• Start date: January 14, 2021
• Est. completion date: March 3, 2021

Study information

• Verified date: April 2021
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Peposertib
Participants will receive single oral dose of Peposertib tablet under fasting (Treatment A) or fed (Treatment B) conditions.
• Peposertib
Participants will receive oral suspension dose of peposertib tablets under fasted condition (Treatment C) in either period 1, 2 or 3 of part 1.

Locations

Country	Name	City	State
Germany	Nuvisan GmbH	Gauting
Germany	Nuvisan GmbH	Neu-Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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

External Links

•   Trial Awareness and Transparency website