To Assess the Excretion Balance and Pharmacokinetics of a Single Oral Dose of [14C]SB-681323 in Healthy Adult Males
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|ClinicalTrials.gov Identifier: NCT00564746|
Recruitment Status : Completed
First Posted : November 28, 2007
Last Update Posted : August 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: A single 10 milligram (50 microcurie) oral dose of [14C]SB-681323||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Study to Investigate the Excretion Balance of SB-681323 in Healthy Male Volunteers [Type 3C]|
|Actual Study Start Date :||September 20, 2007|
|Actual Primary Completion Date :||October 26, 2007|
|Actual Study Completion Date :||October 26, 2007|
Experimental: 6 subjects in a single cohort
Each subject will be administered a single 10 milligrams (50 microcurie) oral dose of [14C]SB-681323.
Drug: A single 10 milligram (50 microcurie) oral dose of [14C]SB-681323
[14C] SB-681323 oral solution, is available as a powder which will be made into a solution of 0.1 milligram/milliliter (0.5 microcurie) [14C] SB-681323 in dextrose and water for injection on the day prior to dosing.
For a 10 milligram/50 microcurie oral dose of [14C]SB-681323, 100 milliliters of 0.1 milligram/milliliter (0.5 microcurie/milliliter [14C] SB-681323 oral solution will be dosed.
- Urinary and faecal cumulative excretion as a percentage of the total radioactive dose administered over time. [ Time Frame: 168 Hours ]
- AUC(0-8), Cmax, AUC(0-t), tmax and t½ of total radioactivity and SB8681323 in plasma following oral dosing.- Blood:Plasma ratio of total radioactivity.- AEs, ECG, vital signs and clinical laboratory tests (including LFTs). [ Time Frame: 216 Hours ]
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): NCT00564746
|GSK Investigational Site|
|Tranent, West Lothian, United Kingdom, EH33 2NE|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|