Status:
COMPLETED
A Food Effect Study in Healthy Volunteers With Belzutifan (PT2977, MK-6482) Tablets
Lead Sponsor:
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 crite...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03445169
Start Date
February 23 2018
End Date
May 26 2018
Last Update
November 9 2020
Active Locations (1)
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1
Spaulding Clinical
West Bend, Wisconsin, United States, 53095