To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Renal Impaired Subjects and Healthy Subjects



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:March 2014
End Date:May 2014
Contact:Quintiles Drug Research Unit Call Centre
Email:ClinicalTrialTransparency@astrazeneca.com
Phone:0800 634 1132

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An Open Label Comparative Study of the Pharmacokinetics, Safety and Tolerability of Selumetinib (AZD6244, ARRY 142886) (Hyd Sulfate) Following a Single Oral Dose in Subjects With Renal Impairment and Healthy Subjects

A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244,
ARRY-142886) in subjects with renal impairment and healthy subjects

An open label study to assess the pharmacokinetics, safety and tolerability of 50 mg single
oral dose of Selumetinib (AZD6244, ARRY-142886) in subjects with renal impairment and
healthy subjects

Inclusion Criteria all participants:

1. Male and female (non childbearing potential) subjects aged 18 years or more with
suitable veins for cannulation or repeated venipuncture.

2. Have a weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 40
kg/m2, inclusive.

Inclusion healthy volunteers only:

3. Must be in good health as determined by a medical history, physical examination, 12
lead ECG, clinical laboratory evaluations, and an ophthalmic examination performed
before the administration of the investigational product.

Inclusion renal impaired patients only:

4. Stable renal function

Exclusion Criteria all participants:

1. Subjects of Japanese or non Japanese Asian ethnicity.

2. Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese
Asian (e.g. China, Taiwan, Korea, Philippines, Thailand, Vietnam and Malaysia).
Asian Indians are acceptable.

3. Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day

4. In the opinion of the investigator, any evidence of additional severe or uncontrolled
systemic disease (eg, currently unstable or uncompensated hepatic, cardiovascular, or
respiratory disease) or laboratory finding, physical examination, hematology,
clinical chemistry, urinalysis, vital signs, or 12-lead ECG that makes it undesirable
for the subject to participate in the study.

Exclusion renal impaired patients only:

5. Subjects with an active renal transplant (subjects who have previously received a
renal transplant and are currently undergoing dialysis due to transplant failure may
be enrolled).

6. Acute coronary syndrome within 6 months prior to administration of the
investigational product.
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