PK and PD Study of IDN-6556 in Subjects With Severe Renal Impairment and Matched Healthy Volunteers

Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Age Range:18 - 75
Start Date:January 2014
End Date:April 2014

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An Open-Label Pharmacokinetic and Pharmacodynamic Study of a Single Dose of IDN-6556 in Subjects With Severe Renal Impairment and in Matched Healthy Volunteers

This is an open-label, parallel-group study to compare the pharmacokinetics and
pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with
severe renal impairment and matched healthy volunteers with normal renal function.

Inclusion Criteria:

All Subjects:

- Male or female subjects 18 - 75 years of age, able to provide written informed
consent, understand and comply with all scheduled visits, and other requirements of
the study

- Body mass index (BMI) 18.0 - 40.0 kg/m2 and body weight >50 kg

- Willingness to utilize two reliable forms of contraception (for both males and
females of childbearing potential) from screening to one month after the last dose of
study drug

Matched Healthy Volunteers:

- Medically healthy as determined by the Investigator

- Screening creatinine clearance ≥90 mL/min using the Cockcroft-Gault equation

- Supine blood pressure ≤145/90 mmHg

- No significant uncontrolled systemic or major illness that, in the opinion of the
Investigator, would preclude the subject from participating in and completing the

- Demographically comparable to subjects with severe renal impairment as follows:

1. Mean body weight within ±10 kg

2. Mean age within ±5 years

3. Similar gender ratio

Severe Renal Impaired Subjects:

- Screening creatinine clearance (CLCR) <30 mL/min using the Cockcroft-Gault equation

- Supine blood pressure ≤170/110 mmHg

- Documented renal impairment indicated by reduced creatinine clearance within 12
months of screening or longer

- Stable renal function as evidenced by ≤30% difference in two measurements of
creatinine clearance on two separate occasions separated by at least 28 days with one
measurement being the value at screening.

Exclusion Criteria:

- History of renal trasplant

- Acute renal failure

- Subjects undergoing any method of dialysis or hemofiltration

- Evidence or history of clinically significant uncontrolled hematological, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing)

- Disorders or surgery of the gastrointestinal tract which may interfere with drug
absorption or may otherwise influence the pharmacokinetics of the investigational
medicinal product (e.g., inflammatory bowel disease, resections of the small or large
intestine, etc.)

- History of febrile illness within 5 days prior to dosing

- Evidence of clinically significant liver disease or liver damage (e.g., hepatitis B
or C, autoimmune hepatitis, primary biliary cirrhosis, non-alcoholic fatty liver
disease, elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
that is considered clinically significant by the Investigator, etc.)

- Known infection with human immunodeficiency virus (HIV) upon serological testing

- History or presence of clinically concerning cardiac arrhythmias, or prolongation of
Screening (pre-treatment) QT or QTc interval of >480 milliseconds (msec) for subjects
with severe renal impairment or >450 msec for matched healthy volunteers

- Subjects with active or history of malignancies other than curatively treated skin
cancer (basal cell or squamous cell carcinomas)
We found this trial at
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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DeLand, FL
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Miami, Florida 33124
(305) 284-2211
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Miami, FL
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