Who is sponsoring NCT02571140?

NCT02571140 is sponsored by Entera Bio Ltd..

What condition does NCT02571140 study?

NCT02571140 studies Drug Safety and Bioavailability.

What drugs are being tested in NCT02571140?

Interventions: Teriparatide, Oral PTH (1-34).

What is the status of NCT02571140?

NCT02571140 is currently COMPLETED.

Last reviewed 2018-01-09 · How we verify

A Phase Ib Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects

NCT02571140 Phase 1 COMPLETED

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.

Details

Lead sponsor	Entera Bio Ltd.
Phase	Phase 1
Status	COMPLETED
Enrolment	30
Start date	2013-10
Completion	2017-10

Conditions

Drug Safety and Bioavailability

Interventions

Teriparatide
Oral PTH (1-34)

Primary outcomes

Peak Plasma Concentration — 60-522 days
Blood samples for determination of PTH plasma concentrations will be taken at the time points to study the pharmocokinetc profile