Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-GSK706769
GSK706769 · 2 trials · 2 indications
Change from baseline values in clinical chemistry, hematology and urinalysis.
Change from baseline values
Change from baseline values
Area under the plasma concentration time curve (AUC(0-infinity), AUC(0-24)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), concentration at 24 hours post dose (C24), terminal half-life (t1/2), absorption lag time (tlag), apparent clearance (CL/F), metabolite-to-parent molar ratios for AUC(0-t) and Cmax; and following last repeat administration on Day 7 or 8: AUC(0-infinity), concentration at end of dosing interval (Ctau), Cmax, tlag, tmax, t1/2, and CL/F, metabolite-to-parent molar ratios for AUC(0-tau) and Cmax on Day 7 or 8.
| Arm | Type | Description |
|---|---|---|
| [14C]-GSK706769 | EXPERIMENTAL | Single dose of 50µg \[14C\]-GSK706769 containing 250 nCi |
| [14C]-GSK706769 + Ketoconazole | EXPERIMENTAL | An oral, 5-day repeat dose of 200 mg Ketoconazole (Q12) with a concomitant single oral dose of 50 µg \[14C\]-GSK706769 containing 250 nCi on day 3. |
| Cohort A | EXPERIMENTAL | 50mg dose once daily for 7 days. |
| Cohort B | EXPERIMENTAL | 100mg dose once daily for 8 days. |
| Cohort C | EXPERIMENTAL | 200mg dose once daily for 8 days. |
| Cohort D | EXPERIMENTAL | 400mg dose once daily for 7 days. |
| Name | Type | Description |
|---|---|---|
| [14C]-GSK706769 | DRUG | 50µg \[14C\]-GSK706769 containing 250 nCi |
| Ketoconazole | DRUG | 200 mg Ketoconazole (Q12) |
| GSK706769 | DRUG | 50mg, 100mg, 200mg, or 400mg |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Males 18-50 years of age inclusive, at the time of signing the informed consent. * AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5x Upper Limit of Normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin ...
GSK706769 is an investigational small molecule developed by GSK plc for immunology indications, including autoimmune diseases and HIV infection. It has been studied in Phase 1 clinical trials in healthy adult volunteers. It is not an approved medicine and remains in early clinical development.
GSK706769 has been studied in clinical trials for autoimmune diseases and for infection, including human immunodeficiency virus. The trials enrolled healthy adult volunteers rather than patients. No approved use has been established, and the compound remains investigational.
GSK706769 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 studies of the compound conducted in the United States.
GSK706769 is in Phase 1 development. Two Phase 1 trials have been completed, and no active trials are currently listed. The compound is investigational and has not been approved for any indication.
GSK706769 has been evaluated in two completed Phase 1 trials. NCT00975936 was a Phase 0 microdose study in autoimmune diseases with 12 male healthy volunteers. NCT00711386 was a repeat dose study in infection and human immunodeficiency virus with 40 healthy volunteers. Both were conducted in the United States.
Yes. [14C]-GSK706769 is an alternative name for GSK706769. The carbon-14 label refers to a radiolabeled form of the same compound used in the Phase 0 microdose study, NCT00975936, which examined the drug in healthy male volunteers.