Food Effects on Pharmacokinetics
Conditions
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.
Interventions
DRUGMilademetan Treatment A
Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions
DRUGMilademetan Treatment B
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
DRUGMilademetan Treatment C
Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Participants will be assigned to 1 of 6 treatment sequences (Sequences ABC, ACB, BAC, BCA, CAB, or CBA), according to a pre-generated randomization scheme.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy participants with no clinically significant medical history or physical examination findings and who also meet all protocol-defined inclusion and
Exclusion criteria
summarized as follows: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Time to teach maximum plasma concentration (Tmax) of milademetan | within 120 hours postdose in each treatment period | — |
| Apparent volume of distribution (Vz/F) 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 | — |
| AUC from time 0 to the time of last measurable concentration (AUClast) for milademetan | within 120 hours postdose in each treatment period | — |
Countries
United States
Outcome results
None listed