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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01466335 | An Adaptive Phase I Study to Evaluate the Safety, Efficacy and Dose Responses of Ronacaleret in Healthy Human Volunteers | PHASE1 | COMPLETED | 39 | — | — | Oct 27, 2011 | Mar 5, 2012 | Jun 20, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Ronacaleret 100mg once daily | EXPERIMENTAL | 1 x 100mg oral tablet |
| Ronacaleret 100mg twice daily | EXPERIMENTAL | 1 x 100mg oral tablet twice daily |
| Ronacaleret 200mg once daily | EXPERIMENTAL | 2 x 100mg oral tablet |
| Ronacaleret 200mg twice daily | EXPERIMENTAL | 2 x 100mg tablets twice daily |
| Ronacaleret 400mg once daily | EXPERIMENTAL | 4 x 100mg tablets |
| Placebo | PLACEBO_COMPARATOR | Matching number of identical placebo tablets |
| Name | Type | Description |
|---|---|---|
| Ronacaleret (100mg tablet) | DRUG | 100mg tablet |
| Placebo | DRUG | matching placebo tablet |
Inclusion Criteria: * Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac ...