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Completed

NCT Number: NCT03647202

Food Effects on Milademetan Pharmacokinetics in Healthy Participants

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.

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Key information

Conditions

Food Effects on Pharmacokinetics

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Covance Clinical Research Unit, Inc.

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • 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

Treatment and study plan

Milademetan Treatment A

Drug

Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions

Other names: Experimental product

Milademetan Treatment B

Drug

Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal

Other names: Experimental product

Milademetan Treatment C

Drug

Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.

Primary outcomes

  1. 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

  2. Area under the plasma concentration-time curve (AUC) extrapolated to infinity (AUCinf) for milademetan

    Time frame: within 120 hours postdose in each treatment period

Secondary outcomes

  1. Time to teach maximum plasma concentration (Tmax) of milademetan

    Time frame: within 120 hours postdose in each treatment period

  2. AUC from time 0 to the time of last measurable concentration (AUClast) for milademetan

    Time frame: within 120 hours postdose in each treatment period

  3. Lag time (tlag) for milademetan

    Time frame: within 120 hours postdose in each treatment period

    Tlag is used to characterize the delay in absorption of orally administered drugs

  4. Terminal elimination half-life (t½) of milademetan

    Time frame: within 120 hours postdose in each treatment period

  5. Apparent total body clearance (CL/F) of milademetan clearance (CL/F),

    Time frame: within 120 hours postdose in each treatment period

  6. Apparent volume of distribution (Vz/F) of milademetan

    Time frame: within 120 hours postdose in each treatment period

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

An Open-label, Randomized, 3-period, 3-treatment Crossover Study to Evaluate the Effect of High-fat, High-calorie Food and Standard Food on the Single-dose Pharmacokinetics of Milademetan in Healthy Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 27, 2018
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.