CompletedPhase 1

A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants

United States28 participantsStarted 2023-09-19

Plain-language summary

This study will assess the effect of a Proton Pump Inhibitor (PPI) (rabeprazole) on the pharmacokinetics (PK) of PC14586 and the effect of an H2-receptor antagonist (famotidine) on the PK of PC14586

Who can participate

Age range18 Years – 55 Years

SexALL

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 and females, 18-55 years of age, with BMI between 18.5 - 30 kg/m2 inclusive.
✓. Agree to use a highly effective method of contraception from 14 days before check-in through 90 days after last dose of study drug.
✓. Participants who are capable of giving signed informed consent.

Exclusion criteria

✕. Participants with significant history or clinical manifestation of any medical condition, disease or disorder, as determined by the Investigator.
✕. Positive hepatitis panel and/or positive human immunodeficiency virus test.
✕. Use or intend to use any prescription and/or nonprescription medications/products within 14 days prior to check-in.
✕. Participation in a clinical study involving last administration of an investigational drug within the past 30 days prior to screening.
✕. Participant has blood pressure \> 140 mm systolic or \> 90 mm diastolic at Screening or Day - 1.
✕. Participants with a germline TP53 Y220C mutation at Screening.
✕. Participant has smoked or used other nicotine-containing products (snuff, chewing tobacco, cigars, pipes, vaporizer, or nicotine-replacement products such as nicotine chewing gum and nicotine plasters) during the 3 months before the Screening Visit.
✕. Participant has history of alcohol and/or illicit drug abuse within 5 years of Screening.

What they're measuring

Part 1: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with rabeprazole.

Timeframe: 20 days

Part 1: Characterize the total drug exposure to the last measurable concentration (AUC0-last) of PC14586 when co-administered with rabeprazole.

Timeframe: 20 days

Part 1: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with rabeprazole.

Timeframe: 20 days

Part 1: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with rabeprazole.

Timeframe: 20 days

Part 2: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with famotidine.

Timeframe: 20 days

Part 2: Characterize the total drug exposure to the last measurable concentration (AUC0-last) of PC14586 when co-administered with famotidine.

Timeframe: 20 days

Part 2: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with famotidine.

Timeframe: 20 days

Trial details

NCT IDNCT06054464

SponsorPMV Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-03

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range18 Years – 55 Years

SexALL

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 and females, 18-55 years of age, with BMI between 18.5 - 30 kg/m2 inclusive.
✓. Agree to use a highly effective method of contraception from 14 days before check-in through 90 days after last dose of study drug.
✓. Participants who are capable of giving signed informed consent.

Exclusion criteria

✕. Participants with significant history or clinical manifestation of any medical condition, disease or disorder, as determined by the Investigator.
✕. Positive hepatitis panel and/or positive human immunodeficiency virus test.
✕. Use or intend to use any prescription and/or nonprescription medications/products within 14 days prior to check-in.
✕. Participation in a clinical study involving last administration of an investigational drug within the past 30 days prior to screening.
✕. Participant has blood pressure \> 140 mm systolic or \> 90 mm diastolic at Screening or Day - 1.
✕. Participants with a germline TP53 Y220C mutation at Screening.
✕. Participant has smoked or used other nicotine-containing products (snuff, chewing tobacco, cigars, pipes, vaporizer, or nicotine-replacement products such as nicotine chewing gum and nicotine plasters) during the 3 months before the Screening Visit.
✕. Participant has history of alcohol and/or illicit drug abuse within 5 years of Screening.

What they're measuring

Part 1: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with rabeprazole.

Timeframe: 20 days

Part 1: Characterize the total drug exposure to the last measurable concentration (AUC0-last) of PC14586 when co-administered with rabeprazole.

Timeframe: 20 days

Part 1: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with rabeprazole.

Timeframe: 20 days

Part 1: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with rabeprazole.

Timeframe: 20 days

Part 2: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with famotidine.

Timeframe: 20 days

Part 2: Characterize the total drug exposure to the last measurable concentration (AUC0-last) of PC14586 when co-administered with famotidine.

Timeframe: 20 days

Part 2: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with famotidine.

Timeframe: 20 days