Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:June 2015
End Date:October 2015

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A single oral dose study in subjects with hepatic impairment and healthy control subjects.
Subjects will stay at the clinical facility where interval blood samplings will be obtained
and examined for drug effect.


Inclusion Criteria:

- Males and females, ages 18 to 70 years, inclusive

- BMI: 18.5 to 38 kg/m2

- Body weight great or equal to 45.5 kg

- Subjects with hepatic impairment

- Subjects with hepatic impairment must be on a stable dose of medication and/or
treatment regimen

- Healthy subjects to the extent possible matched to the first four subjects with
hepatic impairment with regard to age, body weight, and sex, as determined by no
clinically significant deviation from normal in medical history, physical
examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

- Any major surgery within 4 weeks of study drug administration

- Donation of blood to a blood bank or in a clinical study (except a screening visit)
within 4 weeks of study drug administration (within 2 weeks for plasma only)

- Subject has required additional medication for hepatic encephalopathy within 12
months (6 months for severe hepatic impairment) prior to dosing

- Presence of severe ascites or edema in subjects, as judged by the PI
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825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Miami, Florida 33014
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