Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
PMV Pharmaceuticals, Inc
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.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy, non-smoking male and female Caucasian/ non-Asian or Japanese human volunteers
18 to 55 years of age
Able to swallow tablets.
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
You may not be if
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.
