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A Food Effect Study in Healthy Volunteers With Belzutifan (PT2977, MK-6482) Tablets

NCT ID: NCT03445169

Last Updated: 2020-11-09

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

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-23

Study Completion Date

2018-05-26

Brief Summary

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This Phase 1, single-dose study will be conducted in adult male and female subjects (N = 16) who are in general good health and selected for participation in the study according to the selection criteria. This study will assess the effect of food on the pharmacokinetics of belzutifan Tablets. The study will consist of two periods and will be conducted in a crossover fashion.

Detailed Description

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Subjects will be randomized in equal numbers to two sequences of meal conditions (fasting and non-fasting). Serial blood samples will be collected after dose administration in each period. Subjects will be confined at the clinical research for a portion of each period.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fasting

Belzutifan tablets taken after fasting

Group Type EXPERIMENTAL

Belzutifan

Intervention Type DRUG

Belzutifan Tablets

Non-Fasting

Belzutifan taken after eating a high calorie meal

Group Type EXPERIMENTAL

Belzutifan

Intervention Type DRUG

Belzutifan Tablets

Interventions

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Belzutifan

Belzutifan Tablets

Intervention Type DRUG

Other Intervention Names

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MK-6482, PT2977

Eligibility Criteria

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Inclusion Criteria

* Female or vasectomized male;
* If of childbearing potential, willing to practice methods of birth control;
* If of childbearing potential, must be non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the trial;
* Has a body mass index (BMI) between 19 and 32 kg/m2; Willing and able to give written informed consent for study participation and provide consent for access to medical data;
* Willing and able to cooperate with all aspects of the protocol.

Exclusion Criteria

* Any vaccination within 30 days before start of this study and throughout the study;
* Abnormal blood pressure or pulse rate;
* Abnormal screening electrocardiogram (ECG);
* Receipt of any investigational agent within 30 days;
* A positive history of drug abuse or a positive test result for drug(s) of abuse;
* Female subjects who are planning a pregnancy or are pregnant or lactating.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Spaulding Clinical

West Bend, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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PT2977-103

Identifier Type: OTHER

Identifier Source: secondary_id

6482-002

Identifier Type: -

Identifier Source: org_study_id