Effect of Food on Peposertib PK

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2021-03-03

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Part 1: Peposertib: Treatment Sequence A-B-C

Participants will receive single oral dose of peposertib tablet (Treatment A) on Day 1 under fasted condition in period 1, followed by single oral dose of peposertib tablet (Treatment B) on Day 8 under fed condition in period 2, followed by oral suspension dose of peposertib (Treatment C) on Day 15 under fasted condition in period 3. There will be washout period of 7 days between each treatment period.

Group Type EXPERIMENTAL

Peposertib

Intervention Type DRUG

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

Peposertib

Intervention Type DRUG

Participants will receive oral suspension dose of peposertib tablets under fasted condition (Treatment C) in either period 1, 2 or 3 of part 1.

Part 1: Peposertib Treatment Sequence A-C-B

Participants will receive single oral dose of peposertib tablet (Treatment A) on Day 1 under fasted condition in period 1, followed by oral suspension dose of peposertib (Treatment C) on Day 8 under fasted condition in period 2, followed by single oral dose of peposertib tablet (Treatment B) on Day 15 under fed condition in period 3. There will be washout period of 7 days between each treatment period.

Group Type EXPERIMENTAL

Peposertib

Intervention Type DRUG

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

Peposertib

Intervention Type DRUG

Participants will receive oral suspension dose of peposertib tablets under fasted condition (Treatment C) in either period 1, 2 or 3 of part 1.

Part 1: Peposertib Treatment Sequence B-A-C

Participants will receive single oral dose of peposertib tablet (Treatment B) on Day 1 under fed condition in period 1, followed by single oral dose of peposertib tablet (Treatment A) on Day 8 under fasted condition in period 2, followed by oral suspension dose of peposertib (Treatment C) on Day 15 under fasted condition in period 3. There will be washout period of 7 days between each treatment period.

Group Type EXPERIMENTAL

Peposertib

Intervention Type DRUG

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

Peposertib

Intervention Type DRUG

Participants will receive oral suspension dose of peposertib tablets under fasted condition (Treatment C) in either period 1, 2 or 3 of part 1.

Part 1: Peposertib Treatment Sequence B-C-A

Participants will receive single oral dose of peposertib tablet (Treatment B) on Day 1 under fed condition in period 1, followed by oral suspension dose of peposertib (Treatment C) on Day 8 under fasted condition in period 2, followed by single oral dose of peposertib tablet (Treatment A) on Day 15 under fasted condition in period 3. There will be washout period of 7 days between each treatment period.

Group Type EXPERIMENTAL

Peposertib

Intervention Type DRUG

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

Peposertib

Intervention Type DRUG

Participants will receive oral suspension dose of peposertib tablets under fasted condition (Treatment C) in either period 1, 2 or 3 of part 1.

Part 1: Peposertib: Treatment Sequence C-A-B

Participants will receive oral suspension dose of peposertib (Treatment C) on Day 1 under fasted condition in period 1, followed by single oral dose of peposertib tablet (Treatment A) on Day 8 under fasted condition in period 2, followed by single oral dose of peposertib tablet (Treatment B) on Day 15 under fed condition in period 3. There will be washout period of 7 days between each treatment period.

Group Type EXPERIMENTAL

Peposertib

Intervention Type DRUG

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

Peposertib

Intervention Type DRUG

Participants will receive oral suspension dose of peposertib tablets under fasted condition (Treatment C) in either period 1, 2 or 3 of part 1.

Part 1: Peposertib Treatment Sequence C-B-A

Participants will receive oral suspension dose of peposertib (Treatment C) on Day 1 under fasted condition in period 1, followed by single oral dose of peposertib tablet (Treatment B) on Day 8 under fed condition in period 2, followed by single oral dose of peposertib tablet (Treatment A) on Day 15 under fasted condition in period 3. There will be washout period of 7 days between each treatment period.

Group Type EXPERIMENTAL

Peposertib

Intervention Type DRUG

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

Peposertib

Intervention Type DRUG

Participants will receive oral suspension dose of peposertib tablets under fasted condition (Treatment C) in either period 1, 2 or 3 of part 1.

Part 2: Peposertib Treatment Sequence A-B

Participants will receive single oral dose of peposertib tablet (Treatment A) on Day 1 under fasted condition in period 1, followed by single oral dose of peposertib tablet (Treatment B) on Day 8 under fed condition in period 2. There will be washout period of 7 days between each treatment period.

Group Type EXPERIMENTAL

Peposertib

Intervention Type DRUG

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

Part 2: Peposertib: Treatment Sequence B-A

Participants will receive single oral dose of peposertib tablet (Treatment B) on Day 1 under fed condition in period 1, followed by single oral dose of peposertib tablet (Treatment A) on Day 8 under fasted condition in period 2. There will be washout period of 7 days between each treatment period.

Group Type EXPERIMENTAL

Peposertib

Intervention Type DRUG

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

Interventions

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Peposertib

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

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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MSC2490484A M3814 MSC2490484A M3814

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes