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

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.

Study Overview

• Status: Completed
• Conditions: Drug Safety and Bioavailability
• Intervention / Treatment: Drug: Teriparatide; Drug: Oral PTH (1-34)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 condition which according to the physicians' judgment might confound the results of the study or pose additional risk to the subject by participation in the study.
5. Hemoglobin level > 12.5 g/dl
6. Blood pressure levels with no clinical significance.
7. Negative serology to HIV, Hepatitis B, Hepatitis C.
8. No known drug and alcohol abuse
9. Negative urinary drugs of abuse at screening
10. No sensitivity to dairy products
11. No allergy to soy bean products.
12. No prescription medications taken within one month to enrollment
13. Over-the-counter drugs (including vitamins) taken within 14 days prior to visit 2 are subject to the investigators' discretion for inclusion.
14. No subjects with previous urolithiasis.
15. Non-smoking In good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening

Exclusion Criteria:

1. Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
2. Treatment with any investigational product within the last 30 days, enrollment or intention to enroll in any active study involving the use of investigational devices or drugs.
3. Presence of any other condition or circumstance that, in the judgment of the Investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
4. Active infections
5. History of drug or alcohol abuse
6. Known allergies or sensitivities to components of study treatment or study procedures, including Soy.
7. Clinically diagnosed psychiatric disorders that may interfere with patient study participation
8. Medical history known or suspected to increase risks of AEs related to study drug, up to the investigator's discretion
9. Chronic illnesses, up to the investigator's discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator; Subcutaneous injection of Teriparatide	Drug: Teriparatide; subcutaneous standard injection
Experimental: Oral PTH (1-34); Oral administration of pill with API with different optimizations	Drug: Oral PTH (1-34); Different optimization of API; Other Names: Teriparatide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	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	60-522 days

Collaborators and Investigators

• Sponsor: Entera Bio Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimate): October 8, 2015

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Teriparatide; Parathyroid Hormone
• Other Study ID Numbers: ENT-02-2013