To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic … (NCT04831944) | Clinical Trial Compass
CompletedPhase 1
To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic Function and Hepatic Impairment.
United States21 participantsStarted 2021-03-29
Plain-language summary
The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal hepatic function and participants with hepatic impairment.
Who can participate
Age range
18 Years – 80 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:
* Participants with hepatic impairment.
* Participants eligible for Group 4 should be in good health.
* Participants eligible for Groups 1 through 3 may have medical findings consistent with their degree of hepatic dysfunction.
* Participants with abnormal findings considered not clinically significant by the investigator are eligible.
* Body mass index within the range of 18.0 to 40.0 kg/m2 (inclusive) at screening.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
* Evidence of rapidly deteriorating hepatic function.
* Participants with serum calcium and phosphorus levels over the upper limits of the institutional normal ranges.
* History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including any of the following:
* Participants who have a current, functioning organ transplant or have a scheduled organ transplant in the next 6 weeks from check-in.
* History of malignancy within 5 years of screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
* History of clinically significant gastrointestinal disease or surgery (cholecystectomy and appendectomy are allowed) that could impact the absorption of study drug.
* Participants with severe ascites or an encephalopathy ≥ Grade 2.
* Any major surgery within 4 weeks of screening.
* Donation of blo…
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
Pharmacokinetics Parameter : Cmax of parsaclisib
Timeframe: 5 Days
2
Pharmacokinetics Parameter : AUC 0-∞ of parsaclisib
Timeframe: 5 Days
3
Pharmacokinetics Parameter : AUC(0-t) of parsaclisib