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Completed

NCT Number: NCT03614455

Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy Participants

This will be an open-label, randomized, 3-treatment, 2-period, 2-sequence study in healthy subjects to evaluate the single-dose PK of milademetan when given as monotherapy and when administered with steady-state levels of the strong CYP3A4 inhibitors itraconazole or posaconazole.

The duration of the study for each individual subject will be approximately 49 days from the start of Screening through Study Discharge. Subjects will remain in-house for up to 23 days, including 22 overnight stays.

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Key information

Conditions

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

Drug

Milademetan 100 mg capsule for oral administration

Other names: Experimental product, DS-3032, CYP3A4 Substrate

Itraconazole

Drug

Itraconazole (200 mg) oral solution (20 mL of 10 mg/mL)

Other names: CYP3A4 Inhibitor

Posaconazole

Drug

Posaconazole (200 mg) oral suspension (5 mL of 40 mg/mL)

Other names: CYP3A4 Inhibitor

Primary outcomes

  1. Maximum plasma concentration (Cmax) of milademetan

    Time frame: pre-dose and then at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose

    Categories: alone (A), in sequence AB, in sequence AC

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

    Time frame: within 168 hours postdose

    Categories: alone (A), in sequence AB, in sequence AC

Secondary outcomes

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

    Time frame: pre-dose and then at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose

    Categories: alone (A), in sequence AB, in sequence AC

  2. Area under the plasma concentration-time curve from time 0 to the time of last measurable concentration (AUC0-t) for milademetan

    Time frame: within 168 hours postdose

    Categories: alone (A), in sequence AB, in sequence AC

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

    Time frame: within 168 hours postdose

    Categories: alone (A), in sequence AB, in sequence AC

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

    Time frame: within 168 hours postdose

    Categories: alone (A), in sequence AB, in sequence AC

  5. Apparent volume of distribution (Vz/F)

    Time frame: within 168 hours postdose

    Categories: alone (A), in sequence AB, in sequence AC

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

An Open-label, Randomized, 2-period, 2-sequence Study to Evaluate the Single-dose Pharmacokinetics of Milademetan When Administered Alone or Concomitantly With Itraconazole or Posaconazole in Healthy Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 3, 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.

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