Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for autoimmune diseases, infection, and human immunodeficiency virus (HIV). It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
GSK706769 is being developed by GSK plc, a biopharmaceutical company traded on the New York Stock Exchange under the ticker GSK. The drug is currently in Phase 1 clinical trials.
GSK706769 is in Phase 1 clinical development. It has completed two early-stage trials, including a repeat dose study and a microdose study, and remains investigational.
GSK706769 has been studied in two completed Phase 1 trials. NCT00711386 was a repeat dose study in healthy volunteers and individuals with HIV infection, and NCT00975936 was a microdose study in healthy male volunteers for autoimmune diseases.
GSK706769 is the primary name for this investigational compound. No alternative names have been associated with it in clinical trial records.