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

NCT05249348 | Completed Phase 1 FDA Drug

• 2 other identifiers: PMV-586-102262612
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Y220C; PC14586; PMV Pharma; PMV; food effect; Pharmacokinetics; Japanese

Outcome Measures

Primary Outcomes (8)

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

  2 months

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

  2 months

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

  2 months

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

  2 months

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

  7 months

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

  7 months

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

  7 months

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

  7 months

Secondary Outcomes (10)

• Part 1: Treatment emergent adverse events (TEAE)

  5 months

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

  5 months

• Part 2: AUC0-last of PC14586

  6 months

• Part 2: AUC0-inf of PC14586

  6 months

• Part 2: Cmax of PC14586

  6 months

Study Arms (5)

Part 1 Sequence A

EXPERIMENTAL

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

Drug: PC14586

Part 1 Sequence B

EXPERIMENTAL

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

Drug: PC14586

Part 2 Sequence C

EXPERIMENTAL

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

Drug: PC14586

Part 2 Sequence D

EXPERIMENTAL

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

Drug: PC14586

Part 2 Japanese Cohort

EXPERIMENTAL

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

Drug: PC14586

Interventions

PC14586 DRUG

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).

Part 1 Sequence A; Part 1 Sequence B; Part 2 Japanese Cohort; Part 2 Sequence C; Part 2 Sequence D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, non-smoking male and female Caucasian/ non-Asian or Japanese human volunteers
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PMV Pharmaceuticals, Inc: lead

Study Sites (1)

Parexel Early Phase Clinical Unit - Los Angeles

Glendale, California, 91206, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-dose crossover study one dose with food and one dose without food.

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 21, 2022
• Study Start: December 20, 2021
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)