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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-13

Study Completion Date

2018-10-01

Brief Summary

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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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Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Prior to dosing on Day 1 of Treatment Period 1, subjects will be assigned to 1 of 2 sequences (sequences AB or AC), according to a pre-generated randomization scheme.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Milademetan alone (A)

During Period 1, participants receive a single 100 mg milademetan oral dose on Study Day 1, with PK sampling to 168 hours post-dose (during the following 7-day washout period)

Group Type EXPERIMENTAL

Milademetan

Intervention Type DRUG

Milademetan 100 mg capsule for oral administration

Milademetan with itraconazole (AB)

During Period 2, participants receive itraconazole, 200 mg twice daily (BID) on Study day 8 and 200 mg once daily (QD) on Study Days 9 through 20, along with a single 100 mg milademetan dose on Day 14

Group Type OTHER

Milademetan

Intervention Type DRUG

Milademetan 100 mg capsule for oral administration

Itraconazole

Intervention Type DRUG

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

Milademetan with posaconazole (AC)

During Period 2, participants receive 200 mg posaconazole three times daily (TID) on Study Days 8 through 20, along with a single 100 mg milademetan dose on Day 14

Group Type OTHER

Milademetan

Intervention Type DRUG

Milademetan 100 mg capsule for oral administration

Posaconazole

Intervention Type DRUG

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

Interventions

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Milademetan

Milademetan 100 mg capsule for oral administration

Intervention Type DRUG

Itraconazole

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

Intervention Type DRUG

Posaconazole

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

Intervention Type DRUG

Other Intervention Names

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Experimental product DS-3032 CYP3A4 Substrate CYP3A4 Inhibitor CYP3A4 Inhibitor

Eligibility Criteria

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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:

1. safety and well-being of the participant or offspring
2. safety of study staff

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes