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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00564746 |
SB-681323 is a p38 MAP kinase inhibitor and is currently under development by GlaxoSmithKline. This will be an open label study conducted at one site. Six healthy male subjects will be enrolled to ensure at least four fully evaluable subjects. Each subject will receive a single 10mg/ 50 µCurie oral dose of [14C]SB-681323. Urine and faecal samples will be collected until 216 h after dosing but subjects may be discharged after 168 h if 90% of the dose is recovered and/or <1% of the dose is excreted in a 24 h period. Blood and plasma will be collected at various sample times after dosing to measure parent drug and total drug-related material. Samples of urine, faeces and plasma will be transferred into separate study to characterise and quantify metabolites in these matrices. Safety will be assessed by adverse event monitoring, vital signs, ECG and clinical laboratory tests.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: SB-681323 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | An Open Label Study to Determine the Excretion Balance and Pharmacokinetics of [14C]SB-681323, Administered as a Single Dose of an Oral Solution to Healthy Adult Male Subjects. |
Estimated Enrollment: | 6 |
Study Start Date: | November 2007 |
Ages Eligible for Study: | 30 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Prescribed or over-the-counter medication within 5 days (or 5 half lives, whichever is longer) prior to the first dosing day, unless the investigator confirms that it will not introduce additional risk or interfere with the study procedures or outcome.
United Kingdom | |
GSK Clinical Trials Call Centre | Recruiting |
Edinburgh, United Kingdom, EH14 4AP | |
Contact: GSK Clinical Trials Call Centre 1-877-379-3718 |
Study Chair: | GSK Clinical Trials, MBBS | GlaxoSmithKline |
Study ID Numbers: | SB681323/011 |
Study First Received: | November 26, 2007 |
Last Updated: | November 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00564746 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
SB-681323, ADME, radiolabel |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Healthy Rheumatic Diseases |
Immune System Diseases |