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Trial record 69 of 734 for:    Area Under Curve AND Bioavailability

A Study to Assess the Absolute Bioavailability of Oral Selumetinib in Healthy Male Volunteers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02238782
Recruitment Status : Completed
First Posted : September 12, 2014
Results First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers Bioavailability Study
Interventions Drug: selumetinib 75mg single dose
Other: [14C] selumetinib IV solution
Enrollment 21
Recruitment Details 21 subjects were enrolled, 12 of these subjects went on to receive treatment
Pre-assignment Details  
Arm/Group Title Selumetinib
Hide Arm/Group Description Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
Period Title: Overall Study
Started 12
Subjects Treated 12
Completed 12
Not Completed 0
Arm/Group Title Selumetinib
Hide Arm/Group Description Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
42  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
0
   0.0%
Male
12
 100.0%
1.Primary Outcome
Title Absolute Bioavailability
Hide Description To calculate absolute bioavailability we used the formula: Area Under the Curve (oral dose)/Area Under the Curve (intravenous dose)*100
Time Frame 0 to 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Selumetinib
Hide Arm/Group Description:
Selumetinib 75 mg oral followed by IV carbon 14 selumetinib (80 micrograms) administered 1 hour 15 minutes after the oral dose.
Overall Number of Participants Analyzed 12
Geometric Mean (90% Confidence Interval)
Unit of Measure: % of bioavailability
62.1
(60.1 to 64.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Selumetinib
Hide Arm/Group Description Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
All-Cause Mortality
Selumetinib
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Selumetinib
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Selumetinib
Affected / at Risk (%) # Events
Total   2/12 (16.67%)    
Nervous system disorders   
Head Ache *  1/12 (8.33%)  1
Skin and subcutaneous tissue disorders   
Acne *  1/12 (8.33%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gabriella Mariani
Organization: AstraZeneca
Phone: +44 7818 523 899
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02238782    
Other Study ID Numbers: D1532C00080
First Submitted: August 8, 2014
First Posted: September 12, 2014
Results First Submitted: October 6, 2015
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016