Status and phase
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About
This is a Phase 1, open-label, parallel-group study in subjects with varying degrees of renal function to assess the safety, tolerability, and Pharmacokinetics of a single 10 mg oral dose of CIN-107.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Active participation in another experimental therapy study of a small molecule other than CIN-107 within 30 days prior to Day 1 or 5 half-lives, whichever is longer; or received a large molecule within 90 days prior to Day 1 or 5 half-lives, whichever is longer;
History of prior organ transplant or planned transplant within 6 months of screening;
Personal or family history of long QT syndrome, torsades de pointes, or other complex ventricular arrhythmias, or family history of sudden death;
History of, or current, clinically significant arrhythmias as judged by the Investigator, including ventricular tachycardia, ventricular fibrillation, chronic persistent atrial fibrillation, sinus node dysfunction, or clinically significant heart block. Subjects with minor forms of ectopy (eg, premature atrial contractions) are not necessarily excluded;
Prolonged QTcF (>450 msec for males or >470 msec for females) based on the average of triplicate ECGs;
Evidence of any of the following clinical measurements:
History of porphyria, myopathy, or active liver disease;
Inadequate venous access;
Current treatment with weight loss medication or prior weight loss surgery (eg, gastric bypass surgery);
Use of a strong inducer of CYP3A4 within 28 days prior to the dose of study drug;
Corticosteroid use (systemic or extensive topical use) within 3 months prior to study drug dosing;
Positive drug or alcohol test result without medical explanation or a history of alcoholism or drug abuse within 2 years prior to study drug dosing as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition;
Typical consumption of ≥14 alcoholic drinks weekly;
Surgical procedures within 4 weeks prior to study drug dosing or planned elective surgery during the study period;
Any clinically significant illness within 4 weeks prior to study drug dosing, unless deemed not clinically significant by the Investigator;
Pregnant, breastfeeding, or planning to become pregnant during the study;
Primary purpose
Allocation
Interventional model
Masking
33 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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