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

November 5, 2020 updated by: Peloton Therapeutics, Inc.

A Single-Dose, Open-Label, Randomized, Food Effect Study in Healthy Volunteers With PT2977 Tablets

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • 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
    • Wisconsin
      • West Bend, Wisconsin, United States, 53095
        • Spaulding Clinical

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

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fasting
Belzutifan tablets taken after fasting
Drug: Belzutifan
Belzutifan Tablets
Other Names:
  • PT2977
  • MK-6482,
EXPERIMENTAL: Non-Fasting
Belzutifan taken after eating a high calorie meal
Drug: Belzutifan
Belzutifan Tablets
Other Names:
  • PT2977
  • MK-6482,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Concentrations of belzutifan assessed in both the fasting and non-fasting conditions and compared
Time Frame: 9 days in each of the fasting and non-fasting arms
Blood samples to assess concentrations of belzutifan will be collected throughout the sampling time frame
9 days in each of the fasting and non-fasting arms

Collaborators and Investigators

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

Sponsor

Peloton Therapeutics, 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)

February 23, 2018

Primary Completion (ACTUAL)

May 26, 2018

Study Completion (ACTUAL)

May 26, 2018

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

February 20, 2018

First Posted (ACTUAL)

February 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 6482-002
  • PT2977-103 (OTHER: Pelaton Study ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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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