FindTrial
Sign In

AME Study of [14C]-PC14586 in Healthy Male Participants

A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-PC14586 Following a Single Oral Dose in Healthy Male Participants

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05523687
Enrollment
8
Registered
2022-08-31
Start date
2022-09-06
Completion date
2022-11-30
Last updated
2022-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Volunteers

Keywords

Y220C, PC14586, PMV Pharma, PMV, AME

Brief summary

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

Detailed description

PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. The study will assess the PK, absorption, metabolism, and excretion of \[14C\]-PC14586 following a single dose in healthy male participants. The aim is to recruit approximately 8 participants with a minimum number of 6 evaluable participants. Each participant will be admitted to the study site pre-dose on Day -1 and will remain at the study site until at least Day 14. Participants will receive a single administration of \[14C\]-PC14586 as oral capsules on Day 1. During this study, whole blood, plasma, urine, feces, and vomit samples (if presented) will be collected at various timepoints to characterize the absorption, metabolism, excretion, and PK of \[14C\]-PC14586. The duration of the residential period will be evaluated following the administration of \[14C\]-PC14586 and may be extended to ensure recovery of at least 90% of the total radioactivity, or until less than 1% of dose is recovered in urine and/or feces.

Interventions

DRUG[14C]-PC14586

Single, oral dose of \[14C\]-PC14586

Sponsors

PMV Pharmaceuticals, Inc
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

1. 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. 2. In good health, determined by no clinically significant findings from medical history and evaluations at screening and check-in as assessed by the investigator. 3. Agree to use a highly effective method of contraception from check-in through 90 days after discharge. 4. History of a minimum of 1 bowel movement per day. 5. Creatinine clearance ≥90 mL/min determined using the Cockcroft-Gault equation. 6. Able to swallow capsules.

Exclusion criteria

1. Significant history or clinical manifestation of any medical condition, disease or disorder, as determined by the investigator. 2. Blood pressure \>140 mm systolic or \>90 diastolic at screening or Day -1. 3. Positive hepatitis panel and/or positive human immunodeficiency virus test 4. Use or intend to use any prescription and/or nonprescription medications/products within14 days prior to check-in. 5. 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. 6. Participants who have previously completed or withdrawn from this study or any other study investigating PC14586, or have previously received PC14586. 7. 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. 8. A positive p53 Y220C germline test at screening

Design outcomes

Primary

MeasureTime frameDescription
Characterize the renal clearance (CLr) of PC14586 in urine.1 monthDetermine the renal clearance of PC14586 in urine.
Characterize the half life of total radioactivity (Xt1-t2, feces) of PC14586 excreted in feces.1 monthDetermine half life of total radioactivity of PC14586 excreted in feces.
Characterize the fraction excreted of total radioactivity (fe last, feces) of PC14586 in feces.1 monthDetermine the fraction excreted of total radioactivity of PC14586 in feces.
Characterize the half-life of fraction excreted of total radioactivity (fe t1-t2, feces) of PC14586 in feces.1 monthDetermine half-life of fraction excreted of total radioactivity of PC14586 in feces.
Characterize total radioactivity (Xlast, urine) of PC14586 excreted in urine.1 monthDetermine total radioactivity of PC14586 excreted in urine.
Characterize the half life of total radioactivity (Xt1-t2, urine) of PC14586 excreted in urine.1 monthDetermine half life of total radioactivity of PC14586 excreted in urine.
Characterize the fraction excreted of total radioactivity (fe last, urine) of PC14586 in urine.1 monthDetermine the fraction excreted of total radioactivity of PC14586 in urine.
Characterize the half-life of fraction excreted of total radioactivity (fe t1-t2, urine) of PC14586 in urine.1 monthDetermine half-life of fraction excreted of total radioactivity of PC14586 in urine.
Characterize Maximum Plasma Concentration (Cmax) of PC14586 and PC14586 metabolite M1 (PC16163).1 monthDetermine Cmax for PC14586 and PC16163 in plasma.
Characterize Time to Maximum Plasma Concentration (tmax) of PC14586 and PC14586 metabolite M1 (PC16163).1 monthDetermine tmax for PC14586 and PC16163 in plasma.
Characterize Total Drug Exposure (AUC0-inf) of PC14586 and PC14586 metabolite M1 (PC16163).1 monthDetermine AUC0-inf for PC14586 and PC16163 in plasma.
Characterize Total Drug Exposure to the last measurable concentration (AUC0-t) of PC14586 and PC14586 metabolite M1 (PC16163).1 monthDetermine AUC0-t for PC14586 and PC16163 in plasma.
Characterize the Half-Life (t 1/2) of PC14586 and PC14586 metabolite M1 (PC16163).1 monthDetermine t 1/2 for PC14586 and PC16163 in plasma.
Characterize the Clearance (CL/F) of PC14586 and PC14586 metabolite M1 (PC16163) after oral administration.1 monthDetermine CL/F for PC14586 and PC16163 in plasma.
Characterize the Volume of Distribution (Vd/F) of PC14586 and PC14586 metabolite M1 (PC16163) after oral administration.1 monthDetermine Vd/F for PC14586 and PC16163 in plasma.
Determine the total radioactivity in whole blood and plasma of PC14586 and PC14586 metabolite M1 (PC16163).1 monthDetermine total radioactivity for PC14586 and PC16163 in whole blood and plasma.
Characterize total radioactivity (Xlast, feces) of PC14586 excreted in feces.1 monthDetermine total radioactivity of PC14586 excreted in feces

Secondary

MeasureTime frameDescription
Identification of the incidence and severity of adverse events after administration of PC14586.1 monthNumber of participants with adverse events.
Identification of the incidence of laboratory abnormalities based on hematology, clinical chemistry and urine test results of PC14586.1 monthNumber of participants with an incidence of laboratory abnormalities in test results.
Identification of 12-lead electrocardiogram (ECG) abnormalities after a single dose of PC14586.1 monthNumber of participants with abnormal 12-lead ECG results.
Identification of abnormal blood pressure after a single dose of PC14586.1 monthNumber of participants with abnormal blood pressure.
Identification of abnormal pulse rate after a single dose of PC14586.1 monthNumber of participants with abnormal pulse rate.
Identification of abnormal oral body temperature after a single dose of PC14586.1 monthNumber of participants with abnormal oral body temperature.
Identification of PC14586 metabolite profiles in plasma, urine and feces.1 monthIdentification of PC14586 metabolites in plasma (\>10% relative total drug related exposure) and excreta (\>10% of excreted dose).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026