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Anti-fungal

Itraconazole and PC14586 Interaction in Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by PMV Pharmaceuticals, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate how a medication called PC14586 behaves in the body when taken with itraconazole in healthy individuals.

Who is the study for?

Healthy, non-smoking adults aged 18-55 with a BMI of 18.0-32.0 kg/m2 can join this trial if they don't have significant medical conditions or allergies to the drugs being tested. Women must not be able to bear children, and men must use effective contraception for 3 months post-trial.

What is being tested?

The study is testing how the body processes PC14586 when taken with another drug called Itraconazole in healthy people. Participants will take both medications orally to see if there are any changes in how PC14586 is absorbed and metabolized.

What are the potential side effects?

While specific side effects aren't listed for this trial, common side effects of Itraconazole include nausea, rash, and liver function issues; potential side effects of new drugs like PC14586 are usually identified during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+3 more

Secondary study objectives

Characterize the Maximum Plasma Concentration (Cmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.

Characterize the half-life (t1/2) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.

Characterize the time to peak drug concentration (Tmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PC14586 and ItraconazoleExperimental Treatment2 Interventions

Healthy participants will receive a single, oral dose of PC14586 on day 1. On day 20, participants will receive BID oral doses of itraconazole. On days 21-22, participants will receive a single, oral dose of itraconazole. On day 23, participants will receive a single, oral dose of PC14586 and a single oral dose of itraconazole. On days 24-27, participants will receive a single, oral dose of itraconazole.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PC14586

2021

Completed Phase 1

~80

Itraconazole

2017

Completed Phase 2

~830