A Study of the Pharmacokinetics and Safety of BMS-663068 Administered in Subjects With Normal Renal Function and With Mild, Moderate, Severe and End Stage Renal Dysfunction (ESRD)



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, HIV / AIDS, HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:5/17/2018
Start Date:February 26, 2016
End Date:May 24, 2016

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An Open-label Study to Evaluate the Pharmacokinetics and Safety of BMS-663068 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End‑Stage Renal Dysfunction

An oral dose in healthy and renally impaired subjects to determine the drug effect for
BMS-663068.


Inclusion Criteria (For renal impaired subjects):

- Classification by renal function based on eGFR

- Clinical, ECG, and laboratory findings consistent with renal dysfunction

- BMI of 18.0 to 38.0 kg/m2 inclusive

- Women of child bearing potential (WOCBP) and sexually active fertile men with partners
who are WOCBP must use non-hormonal highly effective birth control

- Slightly different inclusion criteria are defined in the protocol for healthy subjects

Exclusion Criteria:

- History of uncontrolled or unstable cardiovascular, respiratory, hepatic,
gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease
within 6 months of screening

- Evidence of rapidly deteriorating renal function, defined as a screening eGFR that has
decreased from a previous eGFR by ≥ 50% within the last 3 months

- Current or recent (within 3 months of study drug administration) clinically
significant gastrointestinal disease or gastrointestinal surgery (including
cholecystectomy) that could impact the absorption of study drug

- Any major surgery within 4 weeks of study drug administration.

- Other protocol defined exclusion criteria could apply
We found this trial at
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Miami, Florida 33136
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