Healthy Volunteers
Conditions
Keywords
Y220C, PC14586, PMV Pharma, PMV, food effect, Pharmacokinetics, Japanese
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.
Interventions
DRUGPC14586
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).
Sponsors
PMV Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single-dose crossover study one dose with food and one dose without food.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Half-life of PC14586 | 6 months |
| Part 1: Treatment emergent adverse events (TEAE) | 5 months |
| Part 2: Incidence of Treatment emergent adverse events (TEAE) | 10 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 |
| Part 2: Tmax of PC14586 | 6 months |
| Part 2: The apparent clearance (CL/F) of PC14586 | 6 months |
| Part 2: Volume of distribution (Vz/F) of PC14586 | 6 months |
Countries
United States
Outcome results
None listed