Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers (NCT05249348) | Clinical Trial Compass
CompletedPhase 1
Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers
United States34 participantsStarted 2021-12-20
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 day…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Effect of a high-fat meal on AUClast
Timeframe: 2 months
2
Part 1: Effect of a high-fat meal on AUC0-inf
Timeframe: 2 months
3
Part 1: Effect of a high-fat meal on the Tmax
Timeframe: 2 months
4
Part 1: Effect of a high-fat meal on the Cmax
Timeframe: 2 months
5
Part 2: Effect of a high-fat meal on the AUC0-last