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CompletedNCT02571140Updated Jan 10, 2018

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

A Phase 1 interventional study of Teriparatide and Oral PTH (1-34) in Drug Safety and Bioavailability, sponsored by Entera Bio Ltd.. Completed. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-10.

Sponsored by Entera Bio Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Drug Safety and Bioavailability
03

In context

Lead sponsor

Entera Bio Ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Active Comparator

    Subcutaneous injection of Teriparatide

    Drug: Teriparatide

  • Experimental
    Oral PTH (1-34)

    Oral administration of pill with API with different optimizations

    Drug: Oral PTH (1-34)

Interventions

  • DrugTeriparatide

    subcutaneous standard injection

  • DrugOral PTH (1-34)

    Different optimization of API

    Also known as: Teriparatide

06

What researchers measure

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

    Time frame: 60-522 days

Secondary outcomes

  1. 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

    Time frame: 60-522 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02571140
Lead sponsor
Entera Bio Ltd.
Responsible party
Sponsor
First posted
Oct 8, 2015
Start date
Oct 2013
Primary completion
Aug 2017
Completion
Oct 2017
Last update
Jan 10, 2018

Study contacts

Yosef Caraco, MD
principal investigator · Hadassah Ein Kerem Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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