Food Effects on Milademetan Pharmacokinetics in Healthy Participants
- Conditions
- Food Effects on Pharmacokinetics
- Interventions
- Registration Number
- NCT03647202
- Lead Sponsor
- Daiichi Sankyo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
-
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:
- safety and well-being of the participant or offspring
- safety of study staff
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence ABC Milademetan Treatment B 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. Sequence ABC Milademetan Treatment C 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. Sequence ACB Milademetan Treatment B 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. Sequence ACB Milademetan Treatment C 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. Sequence BAC Milademetan Treatment B 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. Sequence BCA Milademetan Treatment A 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. Sequence BCA Milademetan Treatment B 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. Sequence CAB Milademetan Treatment A 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. Sequence CAB Milademetan Treatment B 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. Sequence CAB Milademetan Treatment C 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. Sequence CBA Milademetan Treatment A 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. Sequence CBA Milademetan Treatment B 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. Sequence CBA Milademetan Treatment C 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. Sequence BCA Milademetan Treatment C 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. Sequence ABC Milademetan Treatment A 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. Sequence ACB Milademetan Treatment A 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. Sequence BAC Milademetan Treatment C 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. Sequence BAC Milademetan Treatment A 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.
- Primary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) of milademetan predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose in each treatment period Area under the plasma concentration-time curve (AUC) extrapolated to infinity (AUCinf) for milademetan within 120 hours postdose in each treatment period
- Secondary Outcome Measures
Name Time Method Apparent volume of distribution (Vz/F) of milademetan within 120 hours postdose in each treatment period AUC from time 0 to the time of last measurable concentration (AUClast) for milademetan within 120 hours postdose in each treatment period Time to teach maximum plasma concentration (Tmax) of milademetan within 120 hours postdose in each treatment period Lag time (tlag) for milademetan within 120 hours postdose in each treatment period Tlag is used to characterize the delay in absorption of orally administered drugs
Terminal elimination half-life (t½) of milademetan within 120 hours postdose in each treatment period Apparent total body clearance (CL/F) of milademetan clearance (CL/F), within 120 hours postdose in each treatment period
Trial Locations
- Locations (1)
Covance Clinical Research Unit, Inc.
🇺🇸Dallas, Texas, United States