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

Study Overview
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Brief Summary
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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.

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

Conditions
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Drug Safety and Bioavailability

Intervention / Treatment
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* Drug: Teriparatide
* Drug: Oral PTH (1-34)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Over-the-counter drugs (including vitamins) taken within 14 days prior to visit 2 are subject to the investigators' discretion for inclusion. 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |