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A single 10 milligram dose of SB-681323

Phase 1

Pulmonary Disease, Chronic Obstructive | Small molecule | Respiratory |GSK plc|Last Updated: Aug 4, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment4

FDA Designations

No designations recorded

Clinical trial landscape

A single 10 milligram dose of SB-681323 · 1 trial · 1 indication

Phase 1 1
NCT00564746To Assess the Excretion Balance and Pharmacokinetics of a Single Oral Dose of [14C]SB-681323 in Healthy Adult MalesPulmonary Disease, Chronic Obstructive
COMPLETED4 Analytics
PHASE1COMPLETED
To Assess the Excretion Balance and Pharmacokinetics of a Single Oral Dose of [14C]SB-681323 in Healthy Adult Males
Pulmonary Disease, Chronic Obstructive
NCT005647464
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Study Endpoints

Primary Endpoints

Urinary and faecal cumulative excretion as a percentage of the total radioactive dose administered over time.
168 Hours

Secondary Endpoints

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).
216 Hours
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
6 subjects in a single cohortEXPERIMENTALEach subject will be administered a single 10 milligrams (50 microcurie) oral dose of \[14C\]SB-681323.

Interventions

NameTypeDescription
A single 10 milligram (50 microcurie) oral dose of [14C]SB-681323DRUG\[14C\] 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.
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Eligibility Criteria

Age Range30 Years to 60 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male aged between 30 and 60 years inclusive, at the time of screening. * Body weight = 50 kg (110 lbs). * A body mass index (BMI) within the range of 18.5 to 29.9 kg/m2 inclusive. * Signed and dated written informed consent prior to admission to the study. * The subjec...

Countries:United Kingdom
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