Status:
COMPLETED
Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers
Lead Sponsor:
PMV Pharmaceuticals, Inc
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 Japan...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05249348
Start Date
December 20 2021
End Date
June 9 2022
Last Update
November 13 2024
Active Locations (1)
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1
Parexel Early Phase Clinical Unit - Los Angeles
Glendale, California, United States, 91206