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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
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Solid Tumours Drug: Selumetinib Drug: Moxifloxacin Drug: selumetinib placebo Phase 1

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

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Selumetinib 75mg
Volunteers will receive selumetinib 75mg administered by mouth, as a capsule
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
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.
Drug: selumetinib placebo
Volunteers will receive selumetinib placebo oral dose (Treatment C)
Other Name: AZD6244 placebo




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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


Information from the National Library of Medicine

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


Locations
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United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Scott Rasmussen, MD Quintiles 6700 W 115th Street, Kansas, US

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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
Keywords provided by AstraZeneca:
Phase I, healthy, pharmacokinetics
Additional relevant MeSH terms:
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Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs