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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02202603 | A Three Stage, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in Healthy Subjects | PHASE1 | COMPLETED | 42 | — | — | Jul 1, 2011 | Aug 1, 2013 | Oct 7, 2015 | 1 | Israel |
throughout the study beginning from the time the subject signs the consent form until the end of study, subjects will complete the following evaluations: * Vital signs (blood pressure, heart rate, oral temperature) * Clinical laboratory evaluations, hematology, chemistry * Physical Exam * ECG
| Arm | Type | Description |
|---|---|---|
| Teriparatide group 1 | ACTIVE_COMPARATOR | Subcutaneous injection of Teriparatide |
| excipients | PLACEBO_COMPARATOR | Oral pill without API |
| API | EXPERIMENTAL | Oral administration of pill with API |
| API optimization 1 | EXPERIMENTAL | Oral administration of pill with API, for PK optimization #1 |
| API optimization 2 | EXPERIMENTAL | Oral administration of pill with API, for PK optimization #2 |
| API optimization 3 | EXPERIMENTAL | Oral administration of pill with API, for PK optimization #3 |
| API optimization 4 | EXPERIMENTAL | Oral administration of pill with API, for PK optimization #4 |
| API optimization 5 | EXPERIMENTAL | Oral administration of pill with API, for PK optimization #5 |
| API optimization 6 | EXPERIMENTAL | Oral administration of pill with API, for PK optimization #6 |
| API optimization 7 | EXPERIMENTAL | Oral administration of pill with API, for PK optimization #7 |
| Teriparatide group 2 | ACTIVE_COMPARATOR | Subcutaneous injection of Teriparatide |
| API Optimized | EXPERIMENTAL | expanded group size with API in optimized dosage and administration form. |
| Name | Type | Description |
|---|---|---|
| Teriparatide | DRUG | single oral tablet |
| placebo | DRUG | Oral placebo |
Inclusion Criteria: * ● Signed Informed consent to the study. * Male and female volunteers ,aged 18 - 50 years, BMI 18-30 kg/m2, inclusive, * Subjects able to adhere to the visit schedule and protocol requirements * Hematology ,Chemistry and Urinalysis values with no clinical significance or...