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Completed

NCT Number: NCT02056392

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

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

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Key information

Conditions

Solid Tumours

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Overland Park, Kansas, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Selumetinib

Drug

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

Other names: AZD6244

moxifloxacin

Drug

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

Other names: Avelox®

selumetinib placebo

Drug

Volunteers will receive selumetinib placebo oral dose (Treatment C)

Other names: AZD6244 placebo

Primary outcomes

  1. Change From Baseline in QTcF

    Time frame: 30 min

    Change from baseline in QTcF at 30 minutes (msec)

  2. Change From Baseline in QTcF

    Time frame: 1 hour

    Change from baseline in QTcF at 1 hour (msec)

  3. Change From Baseline in QTcF

    Time frame: 1 hour 30 min

    Change from baseline in QTcF at 1 hour 30 min (msec)

  4. Change From Baseline in QTcF

    Time frame: 2 hours

    Change from baseline in QTcF at 2 hours (msec)

  5. Change From Baseline in QTcF

    Time frame: 3 hours

    Change from baseline in QTcF at 3 hours (msec)

  6. Change From Baseline in QTcF

    Time frame: 4 hours

    Change from baseline in QTcF at 4 hours (msec)

  7. Change From Baseline in QTcF

    Time frame: 6 hours

    Change from baseline in QTcF at 6 hours (msec)

  8. Change From Baseline in QTcF

    Time frame: 8 hours

    Change from baseline in QTcF at 8 hours (msec)

  9. Change From Baseline in QTcF

    Time frame: 12 hours

    Change from baseline in QTcF at 12 hours (msec)

  10. Change From Baseline in QTcF

    Time frame: 24 hours

    Change from baseline in QTcF at 24 hours (msec)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, 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 Aged 18 to 45 Years

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 6, 2014
Registry last updated
Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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