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 range

18 Years – 55 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 55 Years

Sex

ALL

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.

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