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

NCT02571140 | Completed Phase 1 DMC

• 1 other identifier: ENT-02-2013
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Events

  60-522 days

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

Subcutaneous injection of Teriparatide

Drug: Teriparatide

Oral PTH (1-34)

EXPERIMENTAL

Oral administration of pill with API with different optimizations

Drug: Oral PTH (1-34)

Interventions

Teriparatide DRUG

subcutaneous standard injection

Active Comparator

Oral PTH (1-34) DRUG

Different optimization of API

Also known as: Teriparatide

Oral PTH (1-34)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed Informed consent to the study.
• Males ,aged 18 - 50 years, BMI 18-30 kg/m2, inclusive,
• Subjects able to adhere to the visit schedule and protocol requirements
• 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.
• Hemoglobin level \> 12.5 g/dl
• Blood pressure levels with no clinical significance.
• Negative serology to HIV, Hepatitis B, Hepatitis C.
• No known drug and alcohol abuse
• Negative urinary drugs of abuse at screening
• No sensitivity to dairy products
• No allergy to soy bean products.
• No prescription medications taken within one month to enrollment
• No subjects with previous urolithiasis.
• Non-smoking In good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening

You may not qualify if:

• Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
• 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.
• 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.
• Active infections
• History of drug or alcohol abuse
• Known allergies or sensitivities to components of study treatment or study procedures, including Soy.
• Clinically diagnosed psychiatric disorders that may interfere with patient study participation
• Medical history known or suspected to increase risks of AEs related to study drug, up to the investigator's discretion
• Chronic illnesses, up to the investigator's discretion

Sponsors & Collaborators

• Entera Bio Ltd.: lead

MeSH Terms

Interventions

Teriparatide; Parathyroid Hormone

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Yosef Caraco, MD

  Hadassah Ein Kerem Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 8, 2015
• Study Start: October 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 10, 2018

Record last verified: 2018-01