Trials / Completed
CompletedNCT02571140
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects
A Phase Ib Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Entera Bio Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This study will have one stage consisting of multiple treatment visits. The study is designed to assess the safety and bioavailability of Entera's oral PTH(1 - 34) in adult male healthy volunteers in various formulation. The study is also designed to assess the reproducibility of pharmacokinetic profiles with various formulations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Teriparatide | subcutaneous standard injection |
| DRUG | Oral PTH (1-34) | Different optimization of API |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2017-08-01
- Completion
- 2017-10-01
- First posted
- 2015-10-08
- Last updated
- 2018-01-10
Source: ClinicalTrials.gov record NCT02571140. Inclusion in this directory is not an endorsement.