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

NCT ID: NCT02571140

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-10-31

Brief 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

Drug Safety and Bioavailability

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Comparator

Subcutaneous injection of Teriparatide

Group Type: ACTIVE_COMPARATOR

Teriparatide

Intervention Type: DRUG

subcutaneous standard injection

Oral PTH (1-34)

Oral administration of pill with API with different optimizations

Group Type: EXPERIMENTAL

Oral PTH (1-34)

Intervention Type: DRUG

Different optimization of API

Interventions

Teriparatide

subcutaneous standard injection

Intervention Type: DRUG

Oral PTH (1-34)

Different optimization of API

Intervention Type: DRUG

Other Intervention Names

Teriparatide

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Entera Bio Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yosef Caraco, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Ein Kerem Medical Center

Other Identifiers

ENT-02-2013

Identifier Type: -

Identifier Source: org_study_id