CompletedPhase 1

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

United States8 participantsStarted 2022-09-06

Plain-language summary

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

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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 Participants who have previously completed or withdrawn from this study or any other study investigating PC14586, or have previously received PC14586.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

What they're measuring

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

Timeframe: 1 month

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

Timeframe: 1 month

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

Timeframe: 1 month

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

Timeframe: 1 month

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

Timeframe: 1 month

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

Timeframe: 1 month

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

Timeframe: 1 month

Trial details

NCT IDNCT05523687

SponsorPMV Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-30

View on ClinicalTrials.gov More Healthy Male Volunteers trials

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: 1 month

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

Timeframe: 1 month

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

Timeframe: 1 month

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

Timeframe: 1 month

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

Timeframe: 1 month

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

Timeframe: 1 month

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

Timeframe: 1 month