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

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.

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.