DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Solid Tumours

Intervention: Selumetinib (Drug); Moxifloxacin (Drug); selumetinib (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Scott Rasmussen, MD, Principal Investigator, Affiliation: Quintiles 6700 W 115th Street, Kansas, US

Summary

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

Clinical Details

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

Primary outcome: Effect of a single dose of selumetinib (75 mg) on the change in time-matched QTcF interval compared to placebo.

Secondary outcome:

Pharmacokinetics of selumetinib, N-desmethyl selumetinib, and moxifloxacin by assessment of area under the plasma concentration-time from time zero to infinity (AUC)

Pharmacokinetics of selumetinib, N-desmethyl selumetinib, and moxifloxacin by assessment of area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration AUC(0-t)

Pharmacokinetics of selumetinib and moxifloxacin only, by assessment of apparent volume of distribution at equilibrium, mean residence time (MRT)*CL/F (Vss/F)

Pharmacokinetics of selumetinib and moxifloxacin only, by assessment of apparent systemic plasma clearance (CL/F)

Pharmacokinetics of selumetinib, N-desmethyl selumetinib, and moxifloxacin by assessment of apparent terminal phase of volume at distribution (selumetinib and moxifloxacin only) (Vz/F)

Pharmacokinetics of selumetinib, N-desmethyl selumetinib, and moxifloxacin by assessment of terminal half-life (t1/2).

Pharmacokinetics of selumetinib, N-desmethyl selumetinib, and moxifloxacin by assessment of terminal rate constant (λz)

Pharmacokinetics of selumetinib, N-desmethyl selumetinib, and moxifloxacin by assessment of mean residence time (MRT)

Pharmacokinetics of selumetinib and N-desmethyl selumetinib by assessment of AUC metabolite to parent ratio, N-desmethyl selumetinib (MRAUC)

Pharmacokinetics of selumetinib and N-desmethyl selumetinib by assessment of Cmax metabolite to parent ratio, N-desmethyl selumetinib (MRCmax)

Pharmacokinetics of selumetinib, N-desmethyl selumetinib, and moxifloxacin by assessment of time to Cmax (tmax).

Pharmacokinetics of selumetinib, N-desmethyl selumetinib, and moxifloxacin by assessment of maximum plasma concentration (Cmax)

The effect of selumetinib on additional ECG variables (QT, HR, RR, QRS, PR) and QTcB

The maximum of the mean changes in time-matched QTcF interval after moxifloxacin administration compared to placebo

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

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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.

Locations and Contacts

Research Site, Overland Park, Kansas, United States
Additional Information

Starting date: March 2014
Last updated: August 18, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017