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

Solid Tumours Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056392
• Other study ID #: D1532C00071
• Status: Completed
• Phase: Phase 1
• First received: February 5, 2014
• Last updated: October 7, 2015
• Start date: March 2014
• Est. completion date: August 2014

Study information

• Verified date: September 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Solid Tumours

Intervention

Drug:
• Selumetinib
Volunteers will receive 75 mg selumetinib oral dose (Treatment A)
• Moxifloxacin
Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B)
• selumetinib placebo
Volunteers will receive selumetinib placebo oral dose (Treatment C)

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in QTcF	Change from baseline in QTcF at 30 minutes (msec)	30 min	Yes
Primary	Change From Baseline in QTcF	Change from baseline in QTcF at 1 hour (msec)	1 hour	Yes
Primary	Change From Baseline in QTcF	Change from baseline in QTcF at 1 hour 30 min (msec)	1 hour 30 min	Yes
Primary	Change From Baseline in QTcF	Change from baseline in QTcF at 2 hours (msec)	2 hours	Yes
Primary	Change From Baseline in QTcF	Change from baseline in QTcF at 3 hours (msec)	3 hours	Yes
Primary	Change From Baseline in QTcF	Change from baseline in QTcF at 4 hours (msec)	4 hours	Yes
Primary	Change From Baseline in QTcF	Change from baseline in QTcF at 6 hours (msec)	6 hours	Yes
Primary	Change From Baseline in QTcF	Change from baseline in QTcF at 8 hours (msec)	8 hours	Yes
Primary	Change From Baseline in QTcF	Change from baseline in QTcF at 12 hours (msec)	12 hours	Yes
Primary	Change From Baseline in QTcF	Change from baseline in QTcF at 24 hours (msec)	24 hours	Yes