To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-08-31

Brief Summary

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Study to assess the effect of Selumetinib \[AZD6244; ARRY-142886\] \[Hyd-Sulfate\]), on QTc interval in healthy male volunteers.

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Detailed Description

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A double-blind (Selumetinib \[AZD6244; ARRY-142886\] \[Hyd-Sulfate\]), Placebo-controlled, Open-Label (Moxifloxacin) Positive-controlled, Randomized, Three-period Crossover Study to Assess the Effects of Single Oral Dose of Selumetinib (75 mg) on QTc Interval Compared to Placebo, using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers

Conditions

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Solid Tumours

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Selumetinib 75mg

Volunteers will receive selumetinib 75mg administered by mouth, as a capsule

Group Type EXPERIMENTAL

Selumetinib

Intervention Type DRUG

Volunteers will receive 75 mg selumetinib oral dose (Treatment A)

Moxifloxacin 400 mg

Volunteers will receive moxifloxacin 400mg administered by mouth, as a capsule

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B)

Selumetinib 75mg placebo

Volunteers will receive selumetinib 75mg placebo, administered by mouth, as a capsule.

Group Type PLACEBO_COMPARATOR

selumetinib placebo

Intervention Type DRUG

Volunteers will receive selumetinib placebo oral dose (Treatment C)

Interventions

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Selumetinib

Volunteers will receive 75 mg selumetinib oral dose (Treatment A)

Intervention Type DRUG

Moxifloxacin

Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B)

Intervention Type DRUG

selumetinib placebo

Volunteers will receive selumetinib placebo oral dose (Treatment C)

Intervention Type DRUG

Other Intervention Names

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AZD6244 Avelox® AZD6244 placebo

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: 1. Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg (inclusive). 2. Must have not smoked in the last 30 days prior to screening for this study. 3. Have a calculated creatinine clearance (CrCL) greater than 50 mL/min using the Cockcroft-Gault formula.

Exclusion Criteria: 1. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Subjects where 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. Past history of central serous retinopathy or retinal vein thrombosis,intraocular pressure greater than 21 mmHg or uncontrolled glaucoma. 4. Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs or ECG at baseline in the opinion of the investigator. 5. History or presence of any clinically significant disease or disorder in the opinion of the investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes