Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Pal… (NCT04829773) | Clinical Trial Compass
CompletedPhase 1
Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects
United States48 participantsStarted 2019-01-03
Plain-language summary
Study to evaluate the effect of food and the effect of swallowing capsule whole versus sprinkling on apple sauce on the pharmacokinetics (PK)/bioavailability of palovarotene, and evaluate the effect of palovarotene on the PK of the CYP3A4 substrate midazolam.
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.
Key Inclusion Criteria:
* Generally healthy male or female aged 18 to 55 years, inclusive; body mass index (BMI) of 18 to 30 kg/m2 and a body weight of \>50 kg; resting pulse of \>45 bpm and \<100 bpm; systolic and diastolic blood pressure of \<140/90 mmHg
Key Exclusion Criteria:
* a history or current evidence of a clinically significant or uncontrolled disease, disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
* exposure to synthetic oral retinoids or creams containing retinoids in the past 30 days prior to the signature of the informed consent.
* history or presence of silent infections, including positive tests for human immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2 (HIV-2), hepatitis B virus (HBV), or hepatitis C virus (HCV)
* history of allergy or hypersensitivity to retinoids, gelatin, or lactose
* For the DDI component only, the subject had a history of allergy or hypersensitivity to benzodiazepines, midazolam, cherries, or midazolam formulation excipients
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 (peak) observed plasma drug concentration
Timeframe: Days 1, 2, 3, 6, 7, 8, 11, 12, 13.
2
Time to reach maximum (peak) (t max) observed plasma concentration following drug administration
Timeframe: Days 1, 2, 3, 6, 7, 8, 11, 12, 13
3
Area under the plasma concentration time (AUC 0-last) curve from time zero to the last quantifiable time point, calculated by linear-log trapezoidal summation
Timeframe: Days 1, 2, 3, 6, 7, 8, 11, 12, 13
4
Area under the plasma concentration time curve from time zero to infinity (AUC 0-infinity)
Timeframe: Days 1, 2, 3, 6, 7, 8, 11, 12, 13
5
Apparent terminal disposition rate constant/terminal rate constant yz
Timeframe: Days 1, 2, 3, 6, 7, 8, 11, 12, 13
6
Apparent terminal elimination half-life (t1/2)
Timeframe: Days 1, 2, 3, 6, 7, 8, 11, 12, 13
7
Apparent volume of distribution after oral administration (Vd/F)