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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03445169

Enrollment

Registered

2018-02-26

Start date

2018-02-23

Completion date

2018-05-26

Last updated

2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

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.

Interventions

DRUGBelzutifan

Belzutifan Tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Plasma Concentrations of belzutifan assessed in both the fasting and non-fasting conditions and compared	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026