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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202603
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
Entera Bio Ltd.

Brief Summary:
A Double blinded (oral), Open Label, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in healthy Subjects to establish the safety, tolerability, bioavailability, pharmacokinetic, and pharmacodynamic profile and the of Entera's oral PTH(1 - 34) in adult healthy human volunteers.

Condition or disease Intervention/treatment Phase
Drug Safety Drug: Teriparatide Drug: placebo Phase 1

Detailed Description:
This study will have three stages. Stage 1: Safety and initial bioavailability of Entera's oral EP101 in adult male healthy volunteers. (SA-BA) Stage 2: Assessment of bioavailability and safety of Entera's oral EP101 in adult male healthy volunteers. (SA-BA-PK-PD) Stage 3: Safety, PK, and PD of final dose of Entera's oral PTH(1 - 34) in adult healthy male and female volunteers. (SA-BA-PK-PD)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Three Stage, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in Healthy Subjects
Study Start Date : July 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Teriparatide group 1
Subcutaneous injection of Teriparatide
Drug: Teriparatide
subcutaneous standard injection

Placebo Comparator: excipients
Oral pill without API
Drug: placebo
Oral placebo

Experimental: API
Oral administration of pill with API
Drug: Teriparatide
single oral tablet

Experimental: API optimization 1
Oral administration of pill with API, for PK optimization #1
Drug: Teriparatide
single oral tablet

Experimental: API optimization 2
Oral administration of pill with API, for PK optimization #2
Drug: Teriparatide
single oral tablet

Experimental: API optimization 3
Oral administration of pill with API, for PK optimization #3
Drug: Teriparatide
single oral tablet

Experimental: API optimization 4
Oral administration of pill with API, for PK optimization #4
Drug: Teriparatide
single oral tablet

Experimental: API optimization 5
Oral administration of pill with API, for PK optimization #5
Drug: Teriparatide
single oral tablet

Experimental: API optimization 6
Oral administration of pill with API, for PK optimization #6
Drug: Teriparatide
single oral tablet

Experimental: API optimization 7
Oral administration of pill with API, for PK optimization #7
Drug: Teriparatide
single oral tablet

Active Comparator: Teriparatide group 2
Subcutaneous injection of Teriparatide
Drug: Teriparatide
subcutaneous standard injection

Experimental: Excipients
Oral pill without API
Drug: placebo
Oral placebo

Experimental: API Optimized
expanded group size with API in optimized dosage and administration form.
Drug: Teriparatide
single oral tablet




Primary Outcome Measures :
  1. Adverse events [ Time Frame: up to 17 weeks ]

    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ● Signed Informed consent to the study.

    • Male and female volunteers ,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 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
    • Female subjects must have a negative serum pregnancy test at screening and be willing and able to use a medically acceptable method of birth control (non-hormonal intrauterine device with condom, or diaphragm with condom, or condom with spermicide) from the screening visit through the study termination visit or declare that they are abstaining from sexual intercourse from the screening visit through the study termination visit or are surgically sterile (have undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or post menopausal. Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202603


Locations
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Israel
HMO Clinical Research Center Hadassah Ein Kerem Medical Center
Jerusalem, Israel, 91120,
Sponsors and Collaborators
Entera Bio Ltd.
Investigators
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Principal Investigator: Yosef Caraco, MD Hadassah Ein Kerem Medical Center
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Responsible Party: Entera Bio Ltd.
ClinicalTrials.gov Identifier: NCT02202603    
Other Study ID Numbers: 0020-11-HMO-EnteraBio
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents