Food Effects on Milademetan Pharmacokinetics in Healthy Participants

February 8, 2019 updated by: Daiichi Sankyo, Inc.

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75247
        • Covance Clinical Research Unit, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Sequence ABC
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
Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions
Other Names:
  • Experimental product
Drug: Milademetan Treatment B
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Other Names:
  • Experimental product
Drug: Milademetan Treatment C
Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.
EXPERIMENTAL: Sequence ACB
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
Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions
Other Names:
  • Experimental product
Drug: Milademetan Treatment B
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Other Names:
  • Experimental product
Drug: Milademetan Treatment C
Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.
EXPERIMENTAL: Sequence BAC
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
Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions
Other Names:
  • Experimental product
Drug: Milademetan Treatment B
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Other Names:
  • Experimental product
Drug: Milademetan Treatment C
Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.
EXPERIMENTAL: Sequence BCA
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
Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions
Other Names:
  • Experimental product
Drug: Milademetan Treatment B
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Other Names:
  • Experimental product
Drug: Milademetan Treatment C
Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.
EXPERIMENTAL: Sequence CAB
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
Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions
Other Names:
  • Experimental product
Drug: Milademetan Treatment B
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Other Names:
  • Experimental product
Drug: Milademetan Treatment C
Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.
EXPERIMENTAL: Sequence CBA
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
Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions
Other Names:
  • Experimental product
Drug: Milademetan Treatment B
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Other Names:
  • Experimental product
Drug: Milademetan Treatment C
Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
within 120 hours postdose in each treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to teach maximum plasma concentration (Tmax) of milademetan
Time Frame: within 120 hours postdose in each treatment period
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
within 120 hours postdose in each treatment period
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
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
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
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
within 120 hours postdose in each treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS3032-A-U115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing Time Frame

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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