A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pedi… (NCT05776108) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation
United States24 participantsStarted 2023-03-23
Plain-language summary
This study will assess the relative bioavailability of the CAB DT formulation relative to that of the CAB IR formulation and to assess the effect of food on the CAB DT formulation.
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:
* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent form (ICF).
* Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and electrocardiogram).
* Body weight greater than or equal to (\>=) 50.0 kilograms (kg) (110 pounds \[lbs\]) for males and \>= 45 kg (99 lbs) for females and Body mass index within the range 18.5 to 31.0 kilogram per meter square (kg/m2) (inclusive) at Screening.
* Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Female: A female participant is eligible to participate if she is not pregnant or breastfeeding and is a Women of non child bearing potential (WONCBP) OR Is a Women of child bearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of less than (\<)1 percent (%) per year).
* A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention (i.e., Day-1 of each treatment Period)
* The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregn…
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
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) following administration of CAB DT after a high fat meal
Timeframe: Up to 168 hours
2
Area under the concentration time curve from time zero (pre-dose) extrapolated to last time of quantifiable concentration (AUC[0-last]) following administration of CAB DT after a high fat meal
Timeframe: Up to 168 hours
3
Maximum observed concentration (Cmax) following administration of CAB DT after a high fat meal
Timeframe: Up to 168 hours
4
AUC(0-inf) following administration of CAB DT in fasted state
Timeframe: Up to 168 hours
5
AUC(0-last) following administration of CAB DT in fasted state
Timeframe: Up to 168 hours
6
Cmax following administration of CAB DT in fasted state
Timeframe: Up to 168 hours
7
AUC(0-inf) following administration of CAB IR in fasted state