Food Effects on Milademetan Pharmacokinetics in Healthy Participants
Completed · Early Phase 1
Conditions studied: Food Effects on Pharmacokinetics
In brief
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.
Key facts
- Study ID
- NCT03647202
- Run by
- Daiichi Sankyo
- People needed
- 18
- Starts
- 2018-08-16
- Expected to finish
- 2018-09-13
- Last updated by the study team
- 2019-02-12
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Covance Clinical Research Unit, Inc. — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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