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

PMV Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PC14586

Study type: Interventional

Funder types: Industry

Identifiers

NCT05249348

262612 (Other Identifier)

PMV-586-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 5 patient groups

Part 1 Sequence A

Experimental group

Description:

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

Treatment:

Drug: PC14586

Part 1 Sequence B

Experimental group

Description:

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

Treatment:

Drug: PC14586

Part 2 Sequence C

Experimental group

Description:

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

Treatment:

Drug: PC14586

Part 2 Sequence D

Experimental group

Description:

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

Treatment:

Drug: PC14586

Part 2 Japanese Cohort

Experimental group

Description:

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

Treatment:

Drug: PC14586