← Back to Search

Other

[14C]-PC14586 for Healthy Volunteers

Phase 1
Waitlist Available
Research Sponsored by PMV Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

Study Summary

This trial will study how a new drug is metabolized and eliminated by the body, as well as how much of the drug is present in the body at different time points.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Characterize Maximum Plasma Concentration (Cmax) of PC14586 and PC14586 metabolite M1 (PC16163).
Characterize Time to Maximum Plasma Concentration (tmax) of PC14586 and PC14586 metabolite M1 (PC16163).
Characterize Total Drug Exposure (AUC0-inf) of PC14586 and PC14586 metabolite M1 (PC16163).
+14 more
Secondary outcome measures
Identification of 12-lead electrocardiogram (ECG) abnormalities after a single dose of PC14586.
Identification of PC14586 metabolite profiles in plasma, urine and feces.
Identification of abnormal blood pressure after a single dose of PC14586.
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single, oral dose of [14C]-PC14586Experimental Treatment1 Intervention
Healthy, male participants will receive a single, oral dose of [14C]-PC14586
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[14C]-PC14586
2022
Completed Phase 1
~10

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PMV Pharmaceuticals, IncLead Sponsor
4 Previous Clinical Trials
308 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research require participants to be under 30 years old?

"The age limit for this clinical trial is 55 years old. All patients that wish to participate must be over the age of 18."

Answered by AI

What goals does this research aim to achieve?

"The primary outcome of this study is to characterize the maximum plasma concentration of PC14586 and its metabolite M1 (PC16163) over the course of approximately one month. Secondary outcomes include identifying abnormal pulse rates after a single dose of PC14586, incidence of laboratory abnormalities based on hematology, clinical chemistry and urine test results, and finally, identification of adverse events after administration of PC14586."

Answered by AI

Are new patients currently being accepted for this trial?

"This specific trial, as noted on clinicaltrials.gov, is not currently looking for patients to enroll. The study was first posted on September 6th, 2020 and updated November 15th, 2020. Although this particular trial isn't seeking participants, there are 3 other trials that are actively recruiting right now."

Answered by AI

Might you explain the requirements for participation in this research?

"This trial is looking for 8 male volunteers between the ages of 18 and 55 who are in good health. Participants must also meet the following criteria: Creatinine clearance ≥90 mL/min determined using the Cockcroft-Gault equation., 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"

Answered by AI

Has the FDA cleared [14C]-PC14586 for use?

"Given that [14C]-PC14586 is in Phase 1 of clinical trials, meaning there is limited safety and efficacy data currently available, our team at Power has given it a score of 1."

Answered by AI
~3 spots leftby Apr 2025