Food Effects on Milademetan Pharmacokinetics in Healthy Participants

NCT ID: NCT03647202

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-16
• Study Completion Date: 2018-09-13

Brief Summary

The primary objectives of this trial are:

• To evaluate the effect of a high-calorie, high-fat meal on the single-dose pharmacokinetics (PK) of milademetan
• To evaluate the effect of a standard meal on the single-dose PK of milademetan

The key secondary objective is to evaluate the safety and tolerability of single-dose milademetan in all treatments.

The duration of the study for each individual participant will be approximately 8 weeks from the start of Screening (within 28 days prior to dosing of study drug on Day 1) through the final Follow-up visit or phone call. Participants will remain in the Clinical Research Unit (CRU) from Study Day -2 through Study Day 20 (a total of 22 days and 21 nights).

Participants will receive 3 single doses of study drug (at least 1 week apart) over the course of 15 days.

At the investigator's discretion, participants may be asked to return to the CRU 14 days (±2 days) after final dose of study drug for a follow-up visit.

The end of the study is defined as the date of final follow-up visit of the last subject undergoing the study.

Conditions

Food Effects on Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sequence ABC

Participants receive milademetan in a fasted condition (A), then with a high-calorie, high-fat breakfast (B), then with a standard breakfast (C) - with a washout period between treatments.

Group Type: EXPERIMENTAL

Milademetan Treatment A

Intervention Type: DRUG

Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions

Milademetan Treatment B

Intervention Type: DRUG

Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal

Milademetan Treatment C

Intervention Type: DRUG

Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.

Sequence ACB

Participants receive milademetan in a fasted condition (A), then with a standard breakfast (C), then with a high-calorie, high-fat breakfast (B) - with a washout period between treatments.

Group Type: EXPERIMENTAL

Milademetan Treatment A

Intervention Type: DRUG

Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions

Milademetan Treatment B

Intervention Type: DRUG

Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal

Milademetan Treatment C

Intervention Type: DRUG

Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.

Sequence BAC

Participants receive milademetan with a high-calorie, high-fat breakfast (B), then in a fasted condition (A), then with a standard breakfast (C) - with a washout period between treatments.

Group Type: EXPERIMENTAL

Milademetan Treatment A

Intervention Type: DRUG

Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions

Milademetan Treatment B

Intervention Type: DRUG

Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal

Milademetan Treatment C

Intervention Type: DRUG

Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.

Sequence BCA

Participants receive milademetan with a high-calorie, high-fat breakfast (B), then with a standard breakfast (C), then in a fasted condition (A) - with a washout period between treatments.

Group Type: EXPERIMENTAL

Milademetan Treatment A

Intervention Type: DRUG

Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions

Milademetan Treatment B

Intervention Type: DRUG

Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal

Milademetan Treatment C

Intervention Type: DRUG

Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.

Sequence CAB

Participants receive milademetan with a standard breakfast (C), then in a fasted condition (A), then with a high-calorie, high-fat breakfast (B) - with a washout period between treatments.

Group Type: EXPERIMENTAL

Milademetan Treatment A

Intervention Type: DRUG

Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions

Milademetan Treatment B

Intervention Type: DRUG

Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal

Milademetan Treatment C

Intervention Type: DRUG

Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.

Sequence CBA

Participants receive milademetan with a standard breakfast (C), then with a high-calorie, high-fat breakfast (B), then in a fasted condition (A) - with a washout period between treatments.

Group Type: EXPERIMENTAL

Milademetan Treatment A

Intervention Type: DRUG

Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions

Milademetan Treatment B

Intervention Type: DRUG

Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal

Milademetan Treatment C

Intervention Type: DRUG

Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.

Interventions

Milademetan Treatment A

Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions

Intervention Type: DRUG

Milademetan Treatment B

Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal

Intervention Type: DRUG

Milademetan Treatment C

Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.

Intervention Type: DRUG

Other Intervention Names

Experimental product; Experimental product

Eligibility Criteria

Inclusion Criteria

• Has negative urine test for drugs of abuse, alcohol and tobacco
• If female, is surgically sterile or postmenopausal
• If male, agrees to protocol-defined contraceptive methods
• Has adequate hematologic, hepatic, and renal function as defined by the protocol
• Is able and willing to follow all study procedures
• Has provided a signed informed consent

Exclusion Criteria

• Is female who is pregnant or breastfeeding
• Is unable to swallow oral medication
• Is unable to follow study procedures
• Has creatinine clearance < 90 mL/min at screening
• Is taking or has taken any medications or therapies outside of protocol-defined parameters
• Has history of or a known allergic reaction to azole antifungal agents
• Has any disease or condition that, per protocol or in the opinion of the investigator, might affect:

1. safety and well-being of the participant or offspring

2. safety of study staff

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Study Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

Covance Clinical Research Unit, Inc.

Dallas, Texas, United States

Countries

United States

Other Identifiers

DS3032-A-U115

Identifier Type: -

Identifier Source: org_study_id