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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Solid Tumours

Treatments: Drug: selumetinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02063204

D1532C00081

Details and patient eligibility

About

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

Full description

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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

HV selumetinib Stage 1

Experimental group

Description:

Healthy volunteer (HV)group to receive selumetinib 50mg (2x25mg) orally

Treatment:

Drug: selumetinib

ESRD selumetinib Stage 1

Experimental group

Description:

End stage renal disease (ESRD)patients to recieve selumetinib 50mg (2x25mg) orally

Treatment:

Drug: selumetinib

Selumetinib stage 2

Experimental group

Description:

If deemed necessary patients with mild and/or moderate and/or severe renal impairment will recieve selumetinib 50mg(2x25mg) orally

Treatment:

Drug: selumetinib