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Food Effects on Milademetan Pharmacokinetics in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03647202
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Food Effects on Pharmacokinetics Drug: Milademetan Treatment A Drug: Milademetan Treatment B Drug: Milademetan Treatment C Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be assigned to 1 of 6 treatment sequences (Sequences ABC, ACB, BAC, BCA, CAB, or CBA), according to a pre-generated randomization scheme.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : August 16, 2018
Actual Primary Completion Date : September 13, 2018
Actual Study Completion Date : September 13, 2018
Arms and Interventions
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Arm Intervention/treatment
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 Name: Experimental product

Drug: Milademetan Treatment B
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Other Name: 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 Name: Experimental product

Drug: Milademetan Treatment B
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Other Name: 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 Name: Experimental product

Drug: Milademetan Treatment B
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Other Name: 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 Name: Experimental product

Drug: Milademetan Treatment B
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Other Name: 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 Name: Experimental product

Drug: Milademetan Treatment B
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Other Name: 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 Name: Experimental product

Drug: Milademetan Treatment B
Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
Other Name: Experimental product

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647202


Locations
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United States, Texas
Covance Clinical Research Unit, Inc.
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Director: Clinical Study Leader Daiichi Sankyo, Inc.
More Information
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT03647202    
Other Study ID Numbers: DS3032-A-U115
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
URL: https://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No