Expired Study
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Minneapolis, Minnesota 55404


Purpose:

The purpose of this study is to characterize the effect of renal function on the plasma, urine, and dialysate pharmacokinetic profile of CB-238,618 in humans. The study will also assess the safety profile and tolerability of CB-238,618 in subjects with varying degrees of renal impairment and in healthy subjects.


Criteria:

Inclusion Criteria: - Subjects with renal impairment are to have mild, moderate, or severe renal impairment, or ESRD requiring HD. ESRD subjects requiring HD should have been receiving HD on a three times/week schedule for at least three months preceding the initial dose in this study Exclusion Criteria: - For healthy subjects (Group A): history or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, including clinically significant anemia, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results - For renally impaired subjects (Groups B to E): as above, except that renal insufficiency and other medical conditions commonly associated with renal impairment (eg, hypertension, diabetes, which should be stable for at least three months preceding the initial dose of study medication in this study) are allowed - Clinically significant abnormalities on physical examination, medical history, 12-lead electrocardiogram (ECG), vital signs, or laboratory values, as judged by the investigator or designee. Subjects with renal impairment should have clinical laboratory values consistent with their disease and approved by the investigator - Evidence of clinically significant hepatic impairment including alanine aminotransferase or aspartate aminotransferase > 1.5 × upper limit of normal (ULN) or bilirubin > 1 × ULN - Hemoglobin <8 g/dL, unless considered stable and not clinically significant in the opinion of the investigator in subjects with ESRD and on HD; - Subjects with renal impairment who are not on a chronic stable drug regimen, defined as starting a new drug or changing dosage within 14 days prior to administration of study medication, except for drugs administered in relationship to HD - Subjects with fluctuating or rapidly deteriorating renal function. Assessment of the stability of the subject's renal function will be determined by the investigator - Subject has a currently functioning renal transplant and/or has been on significant immunosuppressant therapy, as determined by the investigator, within the last six months


NCT ID:

NCT02341599


Primary Contact:

Principal Investigator
Christopher Galloway, MD
Davita Clinical Research


Backup Contact:

N/A


Location Contact:

Minneapolis, Minnesota 55404
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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