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Anti-fungal

PC14586 and Itraconazole for Healthy Subjects

Phase 1

Recruiting

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

~40

Itraconazole

2017

Completed Phase 2

~780

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PMV Pharmaceuticals, IncLead Sponsor

4 Previous Clinical Trials

300 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the clinical trial open to individuals below the age of 80?

"Individuals aged 18 to under 55 are eligible for participation in this clinical trial."

Answered by AI

What is the upper limit for the number of participants being admitted to this clinical trial?

"Indeed, data on clinicaltrials.gov highlights that this investigation is actively seeking volunteers. Originally shared on March 28th, 2024, with the most recent update occurring on April 8th of the same year. The trial aims to recruit a total of 16 participants at one specific site."

Answered by AI

Are patients currently able to participate in this ongoing trial?

"Indeed, the information on clinicaltrials.gov specifies that this research endeavor is actively seeking suitable candidates. The trial was initially listed on March 28th, 2024 and underwent its most recent update on April 8th, 2024. A total of 16 participants are sought from a solitary study site."

Answered by AI

What are the primary goals and objectives of this medical study?

"The principal objective of this research is to delineate the highest plasma concentration (Cmax) of PC14586 when combined with itraconazole in healthy volunteers, a process expected to span about 6 weeks. Subsequent goals encompass elucidating the half-life (t1/2) of PC14586's metabolites M13 and M14 under concurrent administration with itraconazole in these participants, recognizing any abnormalities evident on a 12-lead electrocardiogram (ECG) following PC14586 solo usage or alongside itraconazole among healthy individuals, as well as characterizing the maximum plasma concentration (Cmax"

Answered by AI

Have PC14586 and Itraconazole received approval from the FDA?

"Based on our assessment at Power, the safety of PC14586 and Itraconazole is rated as 1 due to the early Phase 1 trial stage with limited data available regarding safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06362642.

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