Clinical trial NCT02571140: A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects
Official title: A Phase Ib Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Safety and Bioavailability
Lead sponsor: Entera Bio Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-08
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Peak Plasma Concentration
timeFrame: 60-522 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 60-522 days
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Ein Kerem Medical Center
name: Yosef Caraco, MD
role: PRINCIPAL_INVESTIGATOR
References: