Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00836225 | Safety, Tolerability and Activity Study of Multiple Doses of ISIS-SGLT2Rx in Healthy Volunteers | PHASE1 | COMPLETED | 103 | — | — | Jan 1, 2009 | Jan 1, 2012 | Feb 3, 2012 | 1 | Netherlands |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | 50 mg ISIS 388626 vs Placebo, s.c. injection |
| B | EXPERIMENTAL | 100 mg ISIS 388626 vs Placebo, s.c. injection |
| C | EXPERIMENTAL | 200 mg ISIS 388626 vs Placebo, s.c. injection |
| D | EXPERIMENTAL | 400 mg ISIS 388626 vs Placebo, s.c. injection |
| AA | EXPERIMENTAL | 50 mg ISIS 388626, 3x over 1 week s.c. injection, weekly s.c. injection for 5 weeks vs Placebo |
| BB | EXPERIMENTAL | 100 mg ISIS 388626, 3x over 1 week s.c. injection, weekly s.c. injection for 5 weeks vs Placebo |
| AAA | EXPERIMENTAL | 50 mg ISIS 388626, weekly s.c. injection for 13 weeks vs Placebo |
| BBB | EXPERIMENTAL | 100 mg ISIS 388626, weekly s.c. injection for 13 weeks vs Placebo |
| CCC | EXPERIMENTAL | 200 mg ISIS 388626, weekly s.c. injection for 13 weeks vs Placebo |
| FFF | EXPERIMENTAL | 50 mg ISIS 388626, weekly s.c. injection for 13 weeks vs Placebo |
| Name | Type | Description |
|---|---|---|
| ISIS 388626 | DRUG | 4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg Placebo: 0.9% sterile saline |
Inclusion Criteria: * Age 18 to 65 years * Male or female gender although females must be post-menopausal or surgically sterile (hysterectomy, oophorectomy or tubal ligation) * Give written informed consent to participate in the study and availability for all study requirements * Fasting plasma glu...