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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249348
• Other study ID #: PMV-586-102
• Secondary ID: 262612
• Status: Completed
• Phase: Phase 1
• Start date: December 20, 2021
• Est. completion date: June 9, 2022

Study information

• Verified date: December 2022
• Source: PMV Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PC14586
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).

Locations

Country	Name	City	State
United States	Parexel Early Phase Clinical Unit - Los Angeles	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
PMV Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Effect of a high-fat meal on AUClast		2 months
Primary	Part 1: Effect of a high-fat meal on AUC0-inf		2 months
Primary	Part 1: Effect of a high-fat meal on the Tmax		2 months
Primary	Part 1: Effect of a high-fat meal on the Cmax		2 months
Primary	Part 2: Effect of a high-fat meal on the AUC0-last		7 months
Primary	Part 2: Effect of a high-fat meal on the AUC0-inf		7 months
Primary	Part 2: Effect of a high-fat meal on the Tmax		7 months
Primary	Part 2: Effect of a high-fat meal on the Cmax		7 months
Secondary	Part 1: Treatment emergent adverse events (TEAE)		5 months
Secondary	Part 1: Clinically relevant changes in: physical examinations, vital signs, clinical laboratory tests, 12-lead triplicate electrocardiogram (ECG)		5 months
Secondary	Part 2: AUC0-last of PC14586		6 months
Secondary	Part 2: AUC0-inf of PC14586		6 months
Secondary	Part 2: Cmax of PC14586		6 months
Secondary	Part 2: Tmax of PC14586		6 months
Secondary	Part 2: The apparent clearance (CL/F) of PC14586		6 months
Secondary	Part 2: Volume of distribution (Vz/F) of PC14586		6 months
Secondary	Half-life of PC14586		6 months
Secondary	Part 2: Incidence of Treatment emergent adverse events (TEAE)		10 months