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A single 10 milligram dose of SB-681323 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 6 subjects in a single cohort | EXPERIMENTAL | Each subject will be administered a single 10 milligrams (50 microcurie) oral dose of \[14C\]SB-681323. |
| Name | Type | Description |
|---|---|---|
| A single 10 milligram (50 microcurie) oral dose of [14C]SB-681323 | DRUG | \[14C\] 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. |
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...
SB-681323 is an investigational small molecule being studied for chronic obstructive pulmonary disease (COPD), a respiratory condition. It has been tested in a Phase 1 clinical trial in healthy adult male volunteers, not in patients with COPD. It is not approved for any use.
SB-681323 is being developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK sponsored the Phase 1 trial of the drug. No other developer or partner is identified for this asset.
SB-681323 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug remains investigational and has not been approved by the FDA or any other regulatory agency for COPD or any other indication.
SB-681323 has been studied in one completed Phase 1 trial, NCT00564746, titled "To Assess the Excretion Balance and Pharmacokinetics of a Single Oral Dose of [14C]SB-681323 in Healthy Adult Males." The trial enrolled 4 healthy male volunteers aged 30 years and older in the United Kingdom.
Yes. [14C]SB-681323 refers to the same compound, SB-681323, labeled with carbon-14 for a pharmacokinetic and excretion balance study. The trial used a single 10 milligram (50 microcurie) oral dose of [14C]SB-681323, which is the radiolabeled form of the drug.