Drug Safety and Bioavailability
Conditions
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.
Interventions
DRUGTeriparatide
subcutaneous standard injection
DRUGOral PTH (1-34)
Different optimization of API
Sponsors
Entera Bio Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 60-522 days | 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 |
Outcome results
None listed