Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT03647202
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.
Study:
NCT03647202
Study Brief:
Protocol Section:
NCT03647202