To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers
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ClinicalTrials.gov Identifier: NCT02056392 |
Recruitment Status :
Completed
First Posted : February 6, 2014
Results First Posted : November 9, 2015
Last Update Posted : November 9, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumours | Drug: Selumetinib Drug: Moxifloxacin Drug: selumetinib placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official 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 |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
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Experimental: Selumetinib 75mg
Volunteers will receive selumetinib 75mg administered by mouth, as a capsule
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Drug: Selumetinib
Volunteers will receive 75 mg selumetinib oral dose (Treatment A)
Other Name: AZD6244 |
Active Comparator: Moxifloxacin 400 mg
Volunteers will receive moxifloxacin 400mg administered by mouth, as a capsule
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Drug: Moxifloxacin
Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B)
Other Name: Avelox® |
Placebo Comparator: Selumetinib 75mg placebo
Volunteers will receive selumetinib 75mg placebo, administered by mouth, as a capsule.
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Drug: selumetinib placebo
Volunteers will receive selumetinib placebo oral dose (Treatment C)
Other Name: AZD6244 placebo |
- Change From Baseline in QTcF [ Time Frame: 30 min ]Change from baseline in QTcF at 30 minutes (msec)
- Change From Baseline in QTcF [ Time Frame: 1 hour ]Change from baseline in QTcF at 1 hour (msec)
- Change From Baseline in QTcF [ Time Frame: 1 hour 30 min ]Change from baseline in QTcF at 1 hour 30 min (msec)
- Change From Baseline in QTcF [ Time Frame: 2 hours ]Change from baseline in QTcF at 2 hours (msec)
- Change From Baseline in QTcF [ Time Frame: 3 hours ]Change from baseline in QTcF at 3 hours (msec)
- Change From Baseline in QTcF [ Time Frame: 4 hours ]Change from baseline in QTcF at 4 hours (msec)
- Change From Baseline in QTcF [ Time Frame: 6 hours ]Change from baseline in QTcF at 6 hours (msec)
- Change From Baseline in QTcF [ Time Frame: 8 hours ]Change from baseline in QTcF at 8 hours (msec)
- Change From Baseline in QTcF [ Time Frame: 12 hours ]Change from baseline in QTcF at 12 hours (msec)
- Change From Baseline in QTcF [ Time Frame: 24 hours ]Change from baseline in QTcF at 24 hours (msec)

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056392
United States, Kansas | |
Research Site | |
Overland Park, Kansas, United States |
Principal Investigator: | Scott Rasmussen, MD | Quintiles 6700 W 115th Street, Kansas, US |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT02056392 |
Other Study ID Numbers: |
D1532C00071 |
First Posted: | February 6, 2014 Key Record Dates |
Results First Posted: | November 9, 2015 |
Last Update Posted: | November 9, 2015 |
Last Verified: | September 2015 |
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