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Completed

NCT Number: NCT04702698

Effect of Food on Peposertib PK

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nuvisan GmbH, Gauting, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peposertib

Drug

Participants will receive single oral dose of Peposertib tablet under fasting (Treatment A) or fed (Treatment B) conditions.

Other names: MSC2490484A, M3814

Primary outcomes

  1. 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

    Time frame: Pre-dose up to 36 hours post-dose

  2. Part 1 and Part 2: Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC-inf) of Peposertib

    Time frame: Pre-dose up to 36 hours post-dose

  3. Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) of Peposertib

    Time frame: Pre-dose up to 36 hours post-dose

Secondary outcomes

  1. Part 1 and Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

    Time frame: Part 1: up to 21 days; Part 2: up to 14 days

  2. 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

    Time frame: Part 1: up to 21 days; Part 2: up to 14 days

  3. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2021
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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