AME Study of [14C]-PC14586 in Healthy Male Participants
Completed · Phase 1
Conditions studied: Healthy Male Volunteers
In brief
This study will assess the PK and rates of elimination and mass balance of total radioactivity from \[14C\]-PC14586
Key facts
- Study ID
- NCT05523687
- Run by
- PMV Pharmaceuticals, Inc
- People needed
- 8
- Starts
- 2022-09-06
- Expected to finish
- 2022-11-30
- Last updated by the study team
- 2022-12-20
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Healthy, non-smoking males of any race, between 18 and 55 years of age, with BMI between 18.0 and 32.0 kg/m2 inclusive.
- In good health, determined by no clinically significant findings from medical history and evaluations at screening and check-in as assessed by the investigator.
- Agree to use a highly effective method of contraception from check-in through 90 days after discharge.
- History of a minimum of 1 bowel movement per day.
- Creatinine clearance ≥90 mL/min determined using the Cockcroft-Gault equation.
- Able to swallow capsules.
You may not qualify if…
- Significant history or clinical manifestation of any medical condition, disease or disorder, as determined by the investigator.
- Blood pressure >140 mm systolic or >90 diastolic at screening or Day -1.
- Positive hepatitis panel and/or positive human immunodeficiency virus test
- Use or intend to use any prescription and/or nonprescription medications/products within14 days prior to check-in.
- Participation in a clinical study involving last administration of an investigational drug within the past 30 days prior to dosing, or within 5 half-lives of the IMP, whichever is longer, or who have participated in more than 3 radiolabeled drug studies in the last 12 months.
- Participants who have previously completed or withdrawn from this study or any other study investigating PC14586, or have previously received PC14586.
- Participants with a history of alcoholism or drug/chemical abuse within 2 years prior to check-in, use of tobacco or nicotine-containing products within 3 months prior to check-in or with a positive drug and/or alcohol test result at check-in.
- A positive p53 Y220C germline test at screening
Where it is running
- Labcorp Clinical Research Unit Inc. — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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