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 range18 Years – 80 Years
SexALL
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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…
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