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Part 2 Sequence D for 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 10 months
Awards & highlights

Study Summary

This is a 2-part Phase 1 cross-over study to assess the effects of food on the pharmacokinetics of PC14586 in healthy volunteers. The pharmacokinetics of PC14586 at a clinically relevant dose in Japanese participants will also be studied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Effect of a high-fat meal on AUC0-inf
Part 1: Effect of a high-fat meal on AUClast
Part 1: Effect of a high-fat meal on the Cmax
+5 more
Secondary outcome measures
Half-life of PC14586
Part 1: Clinically relevant changes in: physical examinations, vital signs, clinical laboratory tests, 12-lead triplicate electrocardiogram (ECG)
Part 1: Treatment emergent adverse events (TEAE)
+7 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 2 Sequence DExperimental Treatment1 Intervention
Period 1 will be fasted, then washout, then Period 2 will be fed. A different dose of PC14586 will be tested.
Group II: Part 2 Sequence CExperimental Treatment1 Intervention
Period 1 will be fed, then washout, then Period 2 will be fasted. A different dose of PC14586 will be tested.
Group III: Part 2 Japanese CohortExperimental Treatment1 Intervention
6 Japanese participants will be administered a single dose of PC14586.
Group IV: Part 1 Sequence BExperimental Treatment1 Intervention
Period 1 will be fasted, then washout, then Period 2 will be fed.
Group V: Part 1 Sequence AExperimental Treatment1 Intervention
Period 1 will be fed, then washout, then Period 2 will be fasted.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PC14586
2021
Completed Phase 1
~40

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
282 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Parexel Early Phase Clinical Unit - Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers
2021. "Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05249348.
~10 spots leftby Apr 2025
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