A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants (NCT05866627) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants
United Kingdom32 participantsStarted 2023-07-04
Plain-language summary
The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy participants.
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:
* Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass index between 18.0 kilogram per square meter (kg/m\^2) and 32.0 kg/m\^2, inclusive, at screening.
* A negative QuantiFERON-TB Gold test result at screening or documentation of a negative result within 3 months before screening.
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter per minute (mL/min)/1.732 m\^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.
Exclusion Criteria:
* Any significant acute or chronic medical illness.
* Current or recent (within 3 months of study drug administration) gastrointestinal (GI) disease that could impact upon the absorption of study treatment.
* GI surgery, including cholecystectomy, that could impact upon the absorption of study treatment, at the investigator's discretion.
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
Maximum observed plasma concentration (Cmax)
Timeframe: Up to 20 Days
2
Time to attain maximum observed plasma concentration (Tmax)
Timeframe: Up to 20 Days
3
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])