Clinical trial NCT02056392: To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumours
Keywords: Phase I, healthy, pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-02-06
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Eligibility 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.

Primary outcomes:
measure: Change From Baseline in QTcF
timeFrame: 30 min
measure: Change From Baseline in QTcF
timeFrame: 1 hour
measure: Change From Baseline in QTcF
timeFrame: 1 hour 30 min
measure: Change From Baseline in QTcF
timeFrame: 2 hours
measure: Change From Baseline in QTcF
timeFrame: 3 hours
measure: Change From Baseline in QTcF
timeFrame: 4 hours
measure: Change From Baseline in QTcF
timeFrame: 6 hours
measure: Change From Baseline in QTcF
timeFrame: 8 hours
measure: Change From Baseline in QTcF
timeFrame: 12 hours
measure: Change From Baseline in QTcF
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: Quintiles 6700 W 115th Street, Kansas, US
name: Scott Rasmussen, MD
role: PRINCIPAL_INVESTIGATOR
References: