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CompletedNCT05249348Updated Nov 13, 2024

Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers

A Phase 1 interventional study of PC14586 in Healthy Volunteers, sponsored by PMV Pharmaceuticals, Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-13.

Sponsored by PMV Pharmaceuticals, Inc · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Jun 2022, 4 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

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.

Read the detailed description

PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the p53 Y220C mutation. This Phase 1 trial will be conducted in 2 parts (Part 1 - pilot and Part 2 - pivotal) to assess the pharmacokinetics of PC14586 in healthy volunteers including Japanese participants.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Y220C
  • PC14586
  • PMV Pharma
  • PMV
  • food effect
  • Pharmacokinetics
  • Japanese
03

In context

Lead sponsor

PMV Pharmaceuticals, Inc is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Healthy, non-smoking male and female Caucasian/ non-Asian or Japanese human volunteers
  • 18 to 55 years of age
  • Able to swallow tablets.

Inclusion criteria for Japanese participants only:

  • Japanese and born in Japan (1st generation)
  • The parents and grandparents of the participant are ethnically Japanese and born in Japan
  • Has undergone no significant change in lifestyle since leaving Japan
  • Has lived \< 10 years outside of Japan

Exclusion Criteria:

  • Clinically significant medical history as determined by the PI.
  • Any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
  • A p53 Y220C mutation.
  • Blood pressure >140 mm systolic or >90 diastolic.
  • Smoked or used other nicotine-containing products during the previous 3 months.
  • History of alcohol and/or illicit drug abuse within the previous 5 years.
  • Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or human immunodeficiency virus (HIV).
  • Positive blood test for ethanol.
  • Positive urine drug test.
  • Pregnancy or breastfeeding.
  • Unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to admission until discharge from the clinical site.
  • Has donated blood within 2 months prior to admission.
  • Has used over-the-counter (OTC) medications (including vitamins), prescription medications or herbal remedies from 14 days prior to admission.
  • Has used an investigational drug within 30 days prior to Screening.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Part 1 Sequence A

    Period 1 will be fed, then washout, then Period 2 will be fasted.

    Drug: PC14586

  • Experimental
    Part 1 Sequence B

    Period 1 will be fasted, then washout, then Period 2 will be fed.

    Drug: PC14586

  • Experimental
    Part 2 Sequence C

    Period 1 will be fed, then washout, then Period 2 will be fasted. A different dose of PC14586 will be tested.

    Drug: PC14586

  • Experimental
    Part 2 Sequence D

    Period 1 will be fasted, then washout, then Period 2 will be fed. A different dose of PC14586 will be tested.

    Drug: PC14586

  • Experimental
    Part 2 Japanese Cohort

    6 Japanese participants will be administered a single dose of PC14586.

    Drug: PC14586

Interventions

  • DrugPC14586

    An oral dose of PC14586 will be used in Arms A and B (Part 1) and a different dose will be used for Arms C and D and the Japanese cohort (Part 2).

06

What researchers measure

Primary outcomes

  1. Part 1: Effect of a high-fat meal on AUClast

    Time frame: 2 months

  2. Part 1: Effect of a high-fat meal on AUC0-inf

    Time frame: 2 months

  3. Part 1: Effect of a high-fat meal on the Tmax

    Time frame: 2 months

  4. Part 1: Effect of a high-fat meal on the Cmax

    Time frame: 2 months

  5. Part 2: Effect of a high-fat meal on the AUC0-last

    Time frame: 7 months

  6. Part 2: Effect of a high-fat meal on the AUC0-inf

    Time frame: 7 months

  7. Part 2: Effect of a high-fat meal on the Tmax

    Time frame: 7 months

  8. Part 2: Effect of a high-fat meal on the Cmax

    Time frame: 7 months

Secondary outcomes

  1. Part 1: Treatment emergent adverse events (TEAE)

    Time frame: 5 months

  2. Part 1: Clinically relevant changes in: physical examinations, vital signs, clinical laboratory tests, 12-lead triplicate electrocardiogram (ECG)

    Time frame: 5 months

  3. Part 2: AUC0-last of PC14586

    Time frame: 6 months

  4. Part 2: AUC0-inf of PC14586

    Time frame: 6 months

  5. Part 2: Cmax of PC14586

    Time frame: 6 months

  6. Part 2: Tmax of PC14586

    Time frame: 6 months

  7. Part 2: The apparent clearance (CL/F) of PC14586

    Time frame: 6 months

  8. Part 2: Volume of distribution (Vz/F) of PC14586

    Time frame: 6 months

  9. Half-life of PC14586

    Time frame: 6 months

  10. Part 2: Incidence of Treatment emergent adverse events (TEAE)

    Time frame: 10 months

07

Study locations

1 site
  • Parexel Early Phase Clinical Unit - Los Angeles
    Glendale, California 91206, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05249348
Lead sponsor
PMV Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Feb 21, 2022
Start date
Dec 20, 2021
Primary completion
Jun 9, 2022
Completion
Jun 9, 2022
Last update
Nov 13, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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