CompletedPhase 1

A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants

United States12 participantsStarted 2024-03-28

Plain-language summary

The purpose of this study is to assess the effect of PC14586 pharmacokinetics when co administered with itraconazole in healthy participants.

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, aged 18-55 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.
✓. Females of non-childbearing potential, males who agree to a highly effective method of contraception from first dose through 3 months after end of study visit.
✓. Participants who are able to swallow tablets and capsules.
✓. Participants who are capable and willing of giving signed informed consent.

Exclusion criteria

✕. Participants with significant medical history or clinical manifestation of any medical condition, disease or disorder, as determined by the investigator.
✕. History of significant hypersensitivity, intolerance, or allergy to itraconazole or any of the excipients or to medicinal products with similar chemical structures, food or other substance.
✕. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
✕. Participant has blood pressure \>140 mmHg systolic or \>90 mmHg diastolic at screening or Day -1.
✕. Prolonged QT interval corrected for heart rate using Fridericia's correction \>450 ms for males and \>470 ms for females at screening.
✕. Positive hepatitis panel and/or positive human immunodeficiency virus test.
✕. Abnormalities in liver function test ALT or AST \>1.5 × upper limit of normal.
✕. Administration of any vaccine including coronavirus disease 2019 vaccine in the past 14 days prior to check-in.

What they're measuring

Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with itraconazole in healthy participants.

Timeframe: 6 weeks

Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with itraconazole in healthy participants.

Timeframe: 6 weeks

Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with itraconazole in healthy participants.

Timeframe: 6 weeks

Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 when co-administered with itraconazole in healthy participants.

Timeframe: 6 weeks

Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 when co-administered with itraconazole in healthy participants.

Timeframe: 6 weeks

Characterize the half-life (t1/2) of PC14586 when co-administered with itraconazole in healthy participants.

Timeframe: 6 weeks

Trial details

NCT IDNCT06362642

SponsorPMV Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-22

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, aged 18-55 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.
✓. Females of non-childbearing potential, males who agree to a highly effective method of contraception from first dose through 3 months after end of study visit.
✓. Participants who are able to swallow tablets and capsules.
✓. Participants who are capable and willing of giving signed informed consent.

Exclusion criteria

✕. Participants with significant medical history or clinical manifestation of any medical condition, disease or disorder, as determined by the investigator.
✕. History of significant hypersensitivity, intolerance, or allergy to itraconazole or any of the excipients or to medicinal products with similar chemical structures, food or other substance.
✕. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
✕. Participant has blood pressure \>140 mmHg systolic or \>90 mmHg diastolic at screening or Day -1.
✕. Prolonged QT interval corrected for heart rate using Fridericia's correction \>450 ms for males and \>470 ms for females at screening.
✕. Positive hepatitis panel and/or positive human immunodeficiency virus test.
✕. Abnormalities in liver function test ALT or AST \>1.5 × upper limit of normal.
✕. Administration of any vaccine including coronavirus disease 2019 vaccine in the past 14 days prior to check-in.

What they're measuring

Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with itraconazole in healthy participants.

Timeframe: 6 weeks

Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with itraconazole in healthy participants.

Timeframe: 6 weeks

Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with itraconazole in healthy participants.

Timeframe: 6 weeks

Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 when co-administered with itraconazole in healthy participants.

Timeframe: 6 weeks

Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 when co-administered with itraconazole in healthy participants.

Timeframe: 6 weeks

Characterize the half-life (t1/2) of PC14586 when co-administered with itraconazole in healthy participants.

Timeframe: 6 weeks