Effect of Food on Peposertib PK

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Peposertib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04702698

MS100036_0040

2020-004187-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 8 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: Peposertib

Drug: Peposertib

Part 1: Peposertib Treatment Sequence A-C-B

Experimental group

Description:

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.

Treatment:

Drug: Peposertib

Drug: Peposertib

Part 1: Peposertib Treatment Sequence B-A-C

Experimental group

Description:

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.

Treatment:

Drug: Peposertib

Drug: Peposertib

Part 1: Peposertib Treatment Sequence B-C-A

Experimental group

Description:

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.

Treatment:

Drug: Peposertib

Drug: Peposertib

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

Experimental group

Description:

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.

Treatment:

Drug: Peposertib

Drug: Peposertib

Part 1: Peposertib Treatment Sequence C-B-A

Experimental group

Description:

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.

Treatment:

Drug: Peposertib

Drug: Peposertib

Part 2: Peposertib Treatment Sequence A-B

Experimental group

Description:

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.

Treatment:

Drug: Peposertib

Drug: Peposertib

Part 2: Peposertib: Treatment Sequence B-A

Experimental group

Description:

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.

Treatment:

Drug: Peposertib

Drug: Peposertib