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

Phase 1

Completed

• Conditions: Solid Tumours
• Interventions: Drug: Selumetinib; Drug: Moxifloxacin; Drug: selumetinib placebo

• Registration Number: NCT02056392
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-06
• Study Start: 2014-03
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2015-07-31
• Status Verified: 2015-09
• Results First Submitted QC: 2015-10-07
• Last Update Submitted: 2015-10-07
• Results First Posted: 2015-11-09
• Last Update Posted: 2015-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Selumetinib 75mg	Selumetinib	Volunteers will receive selumetinib 75mg administered by mouth, as a capsule
Moxifloxacin 400 mg	Moxifloxacin	Volunteers will receive moxifloxacin 400mg administered by mouth, as a capsule
Selumetinib 75mg placebo	selumetinib placebo	Volunteers will receive selumetinib 75mg placebo, administered by mouth, as a capsule.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in QTcF	24 hours	Change from baseline in QTcF at 24 hours (msec)

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States