[14C]-PC14586 for Healthy Male Volunteers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Labcorp Clinical Research Unit Inc., Madison, WI
Healthy Male Volunteers
[14C]-PC14586 - Drug
Eligibility
18 - 65
Male
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Study Summary

This study will assess the PK and rates of elimination and mass balance of total radioactivity from [14C]-PC14586

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

17 Primary · 7 Secondary · Reporting Duration: 1 month

1 month
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).
Characterize Total Drug Exposure to the last measurable concentration (AUC0-t) of PC14586 and PC14586 metabolite M1 (PC16163).
Characterize the Clearance (CL/F) of PC14586 and PC14586 metabolite M1 (PC16163) after oral administration.
Characterize the Half-Life (t 1/2) of PC14586 and PC14586 metabolite M1 (PC16163).
Characterize the Volume of Distribution (Vd/F) of PC14586 and PC14586 metabolite M1 (PC16163) after oral administration.
Characterize the fraction excreted of total radioactivity (fe last, feces) of PC14586 in feces.
Characterize the fraction excreted of total radioactivity (fe last, urine) of PC14586 in urine.
Characterize the half life of total radioactivity (Xt1-t2, feces) of PC14586 excreted in feces.
Characterize the half life of total radioactivity (Xt1-t2, urine) of PC14586 excreted in urine.
Characterize the half-life of fraction excreted of total radioactivity (fe t1-t2, feces) of PC14586 in feces.
Characterize the half-life of fraction excreted of total radioactivity (fe t1-t2, urine) of PC14586 in urine.
Characterize the renal clearance (CLr) of PC14586 in urine.
Characterize total radioactivity (Xlast, feces) of PC14586 excreted in feces.
Characterize total radioactivity (Xlast, urine) of PC14586 excreted in urine.
Determine the total radioactivity in whole blood and plasma of PC14586 and PC14586 metabolite M1 (PC16163).
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.
Identification of abnormal oral body temperature after a single dose of PC14586.
Identification of abnormal pulse rate after a single dose of PC14586.
Identification of the incidence and severity of adverse events after administration of PC14586.
Identification of the incidence of laboratory abnormalities based on hematology, clinical chemistry and urine test results of PC14586.

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Single, oral dose of [14C]-PC14586
1 of 1
Experimental Treatment

8 Total Participants · 1 Treatment Group

Primary Treatment: [14C]-PC14586 · No Placebo Group · Phase 1

Single, oral dose of [14C]-PC14586
Drug
Experimental Group · 1 Intervention: [14C]-PC14586 · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month
Closest Location: Labcorp Clinical Research Unit Inc. · Madison, WI
Photo of madison 1Photo of madison 2Photo of madison 3
2021First Recorded Clinical Trial
1 TrialsResearching Healthy Male Volunteers
3 CompletedClinical Trials

Who is running the clinical trial?

PMV Pharmaceuticals, IncLead Sponsor
2 Previous Clinical Trials
177 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Male Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Creatinine clearance ≥90 mL/min.
You are able to swallow capsules.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.