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

NCT03445169 | Completed Phase 1 FDA Drug

• 2 other identifiers: 6482-002PT2977-103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Plasma Concentrations of belzutifan assessed in both the fasting and non-fasting conditions and compared

  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

Study Arms (2)

Fasting

EXPERIMENTAL

Belzutifan tablets taken after fasting

Drug: Belzutifan

Non-Fasting

EXPERIMENTAL

Belzutifan taken after eating a high calorie meal

Drug: Belzutifan

Interventions

Belzutifan DRUG

Belzutifan Tablets

Also known as: MK-6482,, PT2977

Fasting; Non-Fasting

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Spaulding Clinical

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

belzutifan

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 26, 2018
• Study Start: February 23, 2018
• Primary Completion: May 26, 2018
• Study Completion: May 26, 2018
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)