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Healthy VolunteersPhase 1NCT05249348

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

A Phase 1 study testing PC14586 in people with Healthy Volunteers, run by PMV Pharmaceuticals, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
PC14586
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
20 Dec 2021to 9 Jun 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Parexel Early Phase Clinical Unit - Los Angeles

    Glendale, California, 91206

Other trials in United States

About this study

Official title: A Phase 1 Open-label, Cross-over Study to Assess the Effects of Food on PC14586 Pharmacokinetics in Healthy Volunteers and to Assess PC14586 Pharmacokinetics in Healthy Japanese Volunteers Living in the US

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.

Being tested
PC14586
Keywords
Y220C, PC14586, PMV Pharma, PMV, food effect, Pharmacokinetics, Japanese

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PC14586Drug

    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).

Study groups in NCT05249348
Study groupRoleWhat they receive
Part 1 Sequence AExperimentalPeriod 1 will be fed, then washout, then Period 2 will be fasted.
Receives: Drug: PC14586
Part 1 Sequence BExperimentalPeriod 1 will be fasted, then washout, then Period 2 will be fed.
Receives: Drug: PC14586
Part 2 Sequence CExperimentalPeriod 1 will be fed, then washout, then Period 2 will be fasted. A different dose of PC14586 will be tested.
Receives: Drug: PC14586
Part 2 Sequence DExperimentalPeriod 1 will be fasted, then washout, then Period 2 will be fed. A different dose of PC14586 will be tested.
Receives: Drug: PC14586
Part 2 Japanese CohortExperimental6 Japanese participants will be administered a single dose of PC14586.
Receives: Drug: PC14586

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2 months

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

    Measured: 2 months

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

    Measured: 2 months

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

    Measured: 2 months

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

    Measured: 7 months

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

    Measured: 7 months

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

    Measured: 7 months

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

    Measured: 7 months

Secondary outcomes (10)

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

    Measured: 5 months

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

    Measured: 5 months

  3. Part 2: AUC0-last of PC14586

    Measured: 6 months

  4. Part 2: AUC0-inf of PC14586

    Measured: 6 months

  5. Part 2: Cmax of PC14586

    Measured: 6 months

  6. Part 2: Tmax of PC14586

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

  9. Half-life of PC14586

    Measured: 6 months

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

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2022
  2. Study start20 Dec 2021
  3. Primary completion9 Jun 2022
  4. Study completion9 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Single-dose crossover study one dose with food and one dose without food.
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05249348
Sponsor's protocol ID
PMV-586-102
Other IDs
262612
Status last verified
Nov 2024
First submitted
7 Jan 2022
Last updated
13 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PC14586 in people with Healthy Volunteers, run by PMV Pharmaceuticals, Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Effect of a high-fat meal on AUClast (time frame: 2 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05249348.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.

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