Approval Probability
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Teriparatide · 2 trials · 2 indications
Blood samples for determination of PTH plasma concentrations will be taken at the time points to study the pharmocokinetc profile
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 |
|---|---|---|
| Active Comparator | ACTIVE_COMPARATOR | Subcutaneous injection of Teriparatide |
| Oral PTH (1-34) | EXPERIMENTAL | Oral administration of pill with API with different optimizations |
| 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 | subcutaneous standard injection |
| Oral PTH (1-34) | DRUG | Different optimization of API |
| placebo | DRUG | Oral placebo |
Inclusion Criteria: 1. Signed Informed consent to the study. 2. Males ,aged 18 - 50 years, BMI 18-30 kg/m2, inclusive, 3. Subjects able to adhere to the visit schedule and protocol requirements 4. Hematology ,Chemistry and Urinalysis values with no clinical significance or do not reflect a medical ...
Teriparatide is being studied for drug safety and bioavailability in healthy volunteers. It is an oral formulation of PTH (1-34) being developed by Entera Bio Ltd. The drug is currently in Phase 1 clinical development and is not approved for any indication.
Teriparatide is being developed by Entera Bio Ltd., a biopharmaceutical company traded under the ticker ENTX. The company is conducting clinical trials to assess the safety, pharmacokinetics, and pharmacodynamics of oral PTH (1-34) in healthy subjects.
Teriparatide is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities for any use.
Teriparatide has been studied in two completed Phase 1 trials: NCT02202603, which enrolled 42 healthy subjects in Israel to assess safety, pharmacokinetics, and pharmacodynamics, and NCT02571140, which enrolled 30 healthy male subjects to evaluate safety and bioavailability of different oral formulations.
Teriparatide is a small molecule that acts as a parathyroid hormone (PTH) analog. It is designed to be administered orally and is being studied for its safety and bioavailability. The drug's mechanism involves mimicking the actions of endogenous PTH, which regulates calcium and phosphate metabolism.
Yes, Teriparatide is referred to as oral PTH (1-34) in clinical trial documentation. The trials listed under NCT02202603 and NCT02571140 describe the drug as oral PTH (1-34), indicating that Teriparatide is the same compound being evaluated in these studies.