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

NCT05523687 | Completed Phase 1 FDA Drug

• 1 other identifier: PMV-586-103
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Male Volunteers

Keywords

Y220C; PC14586; PMV Pharma; PMV; AME

Outcome Measures

Primary Outcomes (17)

• Characterize Maximum Plasma Concentration (Cmax) of PC14586 and PC14586 metabolite M1 (PC16163).

  Determine Cmax for PC14586 and PC16163 in plasma.

  1 month

• Characterize Time to Maximum Plasma Concentration (tmax) of PC14586 and PC14586 metabolite M1 (PC16163).

  Determine tmax for PC14586 and PC16163 in plasma.

  1 month

• Characterize Total Drug Exposure (AUC0-inf) of PC14586 and PC14586 metabolite M1 (PC16163).

  Determine AUC0-inf for PC14586 and PC16163 in plasma.

  1 month

• Characterize Total Drug Exposure to the last measurable concentration (AUC0-t) of PC14586 and PC14586 metabolite M1 (PC16163).

  Determine AUC0-t for PC14586 and PC16163 in plasma.

  1 month

• Characterize the Half-Life (t 1/2) of PC14586 and PC14586 metabolite M1 (PC16163).

  Determine t 1/2 for PC14586 and PC16163 in plasma.

  1 month

• Characterize the Clearance (CL/F) of PC14586 and PC14586 metabolite M1 (PC16163) after oral administration.

  Determine CL/F for PC14586 and PC16163 in plasma.

  1 month

• Characterize the Volume of Distribution (Vd/F) of PC14586 and PC14586 metabolite M1 (PC16163) after oral administration.

  Determine Vd/F for PC14586 and PC16163 in plasma.

  1 month

• Determine the total radioactivity in whole blood and plasma of PC14586 and PC14586 metabolite M1 (PC16163).

  Determine total radioactivity for PC14586 and PC16163 in whole blood and plasma.

  1 month

• Characterize total radioactivity (Xlast, feces) of PC14586 excreted in feces.

  Determine total radioactivity of PC14586 excreted in feces

  1 month

• Characterize the half life of total radioactivity (Xt1-t2, feces) of PC14586 excreted in feces.

  Determine half life of total radioactivity of PC14586 excreted in feces.

  1 month

• Characterize the fraction excreted of total radioactivity (fe last, feces) of PC14586 in feces.

  Determine the fraction excreted of total radioactivity of PC14586 in feces.

  1 month

• Characterize the half-life of fraction excreted of total radioactivity (fe t1-t2, feces) of PC14586 in feces.

  Determine half-life of fraction excreted of total radioactivity of PC14586 in feces.

  1 month

• Characterize total radioactivity (Xlast, urine) of PC14586 excreted in urine.

  Determine total radioactivity of PC14586 excreted in urine.

  1 month

• Characterize the half life of total radioactivity (Xt1-t2, urine) of PC14586 excreted in urine.

  Determine half life of total radioactivity of PC14586 excreted in urine.

  1 month

• Characterize the fraction excreted of total radioactivity (fe last, urine) of PC14586 in urine.

  Determine the fraction excreted of total radioactivity of PC14586 in urine.

  1 month

• Characterize the half-life of fraction excreted of total radioactivity (fe t1-t2, urine) of PC14586 in urine.

  Determine half-life of fraction excreted of total radioactivity of PC14586 in urine.

  1 month

• Characterize the renal clearance (CLr) of PC14586 in urine.

  Determine the renal clearance of PC14586 in urine.

  1 month

Secondary Outcomes (7)

• Identification of PC14586 metabolite profiles in plasma, urine and feces.

  1 month

• Identification of the incidence and severity of adverse events after administration of PC14586.

  1 month

• Identification of the incidence of laboratory abnormalities based on hematology, clinical chemistry and urine test results of PC14586.

  1 month

• Identification of 12-lead electrocardiogram (ECG) abnormalities after a single dose of PC14586.

  1 month

• Identification of abnormal blood pressure after a single dose of PC14586.

  1 month

Study Arms (1)

Single, oral dose of [14C]-PC14586

EXPERIMENTAL

Healthy, male participants will receive a single, oral dose of \[14C\]-PC14586

Drug: [14C]-PC14586

Interventions

[14C]-PC14586 DRUG

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

Single, oral dose of [14C]-PC14586

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• PMV Pharmaceuticals, Inc: lead

Study Sites (1)

Labcorp Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 31, 2022
• Study Start: September 6, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)