An Early Phase 1 interventional study of Milademetan Treatment A and Milademetan Treatment B in Food Effects on Pharmacokinetics, sponsored by Daiichi Sankyo. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by Daiichi Sankyo · Early Phase 1, Interventional, and Basic science
The primary objectives of this trial are:
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.
Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Has any disease or condition that, per protocol or in the opinion of the investigator, might affect:
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.
Drug: Milademetan Treatment A · Drug: Milademetan Treatment B · Drug: 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.
Drug: Milademetan Treatment A · Drug: Milademetan Treatment B · Drug: 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.
Drug: Milademetan Treatment A · Drug: Milademetan Treatment B · Drug: 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.
Drug: Milademetan Treatment A · Drug: Milademetan Treatment B · Drug: 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.
Drug: Milademetan Treatment A · Drug: Milademetan Treatment B · Drug: 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.
Drug: Milademetan Treatment A · Drug: Milademetan Treatment B · Drug: Milademetan Treatment C
Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions
Also known as: Experimental product
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Also known as: Experimental product
Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.
Maximum plasma concentration (Cmax) of milademetan
Time frame: 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
Time frame: within 120 hours postdose in each treatment period
Time to teach maximum plasma concentration (Tmax) of milademetan
Time frame: within 120 hours postdose in each treatment period
AUC from time 0 to the time of last measurable concentration (AUClast) for milademetan
Time frame: within 120 hours postdose in each treatment period
Lag time (tlag) for milademetan
Tlag is used to characterize the delay in absorption of orally administered drugs
Time frame: within 120 hours postdose in each treatment period
Terminal elimination half-life (t½) of milademetan
Time frame: within 120 hours postdose in each treatment period
Apparent total body clearance (CL/F) of milademetan clearance (CL/F),
Time frame: within 120 hours postdose in each treatment period
Apparent volume of distribution (Vz/F) of milademetan
Time frame: within 120 hours postdose in each treatment period
Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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