Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers
- Registration Number
- NCT05249348
- Lead Sponsor
- PMV Pharmaceuticals, Inc
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 2 Japanese Cohort PC14586 6 Japanese participants will be administered a single dose of PC14586. Part 2 Sequence C PC14586 Period 1 will be fed, then washout, then Period 2 will be fasted. A different dose of PC14586 will be tested. Part 1 Sequence B PC14586 Period 1 will be fasted, then washout, then Period 2 will be fed. Part 1 Sequence A PC14586 Period 1 will be fed, then washout, then Period 2 will be fasted. Part 2 Sequence D PC14586 Period 1 will be fasted, then washout, then Period 2 will be fed. A different dose of PC14586 will be tested.
- Primary Outcome Measures
Name Time Method Part 2: Effect of a high-fat meal on the Cmax 7 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-inf 7 months Part 1: Effect of a high-fat meal on the Tmax 2 months 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 2: Effect of a high-fat meal on the AUC0-last 7 months Part 2: Effect of a high-fat meal on the Tmax 7 months
- Secondary Outcome Measures
Name Time Method Part 2: AUC0-inf of PC14586 6 months Part 2: Cmax of PC14586 6 months Part 2: Volume of distribution (Vz/F) of PC14586 6 months Half-life of PC14586 6 months Part 2: Incidence of Treatment emergent adverse events (TEAE) 10 months Part 2: The apparent clearance (CL/F) of PC14586 6 months 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: Tmax of PC14586 6 months
Trial Locations
- Locations (1)
Parexel Early Phase Clinical Unit - Los Angeles
🇺🇸Glendale, California, United States