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

P

Peloton Therapeutics

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Belzutifan

Study type

Interventional

Funder types

Industry

Identifiers

NCT03445169
6482-002
PT2977-103 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Fasting
Experimental group
Description:
Belzutifan tablets taken after fasting
Treatment:
Drug: Belzutifan
Non-Fasting
Experimental group
Description:
Belzutifan taken after eating a high calorie meal
Treatment:
Drug: Belzutifan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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