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Completed

NCT Number: NCT03445169

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Spaulding Clinical

West Bend, Wisconsin, 53095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Belzutifan

Drug

Belzutifan Tablets

Other names: MK-6482,, PT2977

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2018
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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