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

October 6, 2015 updated by: Entera Bio Ltd.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120,
        • HMO Clinical Research Center Hadassah Ein Kerem Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Teriparatide group 1
Subcutaneous injection of Teriparatide
Drug: Teriparatide
single oral tablet
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
Drug: Teriparatide
subcutaneous standard injection
Experimental: API optimization 1
Oral administration of pill with API, for PK optimization #1
Drug: Teriparatide
single oral tablet
Drug: Teriparatide
subcutaneous standard injection
Experimental: API optimization 2
Oral administration of pill with API, for PK optimization #2
Drug: Teriparatide
single oral tablet
Drug: Teriparatide
subcutaneous standard injection
Experimental: API optimization 3
Oral administration of pill with API, for PK optimization #3
Drug: Teriparatide
single oral tablet
Drug: Teriparatide
subcutaneous standard injection
Experimental: API optimization 4
Oral administration of pill with API, for PK optimization #4
Drug: Teriparatide
single oral tablet
Drug: Teriparatide
subcutaneous standard injection
Experimental: API optimization 5
Oral administration of pill with API, for PK optimization #5
Drug: Teriparatide
single oral tablet
Drug: Teriparatide
subcutaneous standard injection
Experimental: API optimization 6
Oral administration of pill with API, for PK optimization #6
Drug: Teriparatide
single oral tablet
Drug: Teriparatide
subcutaneous standard injection
Experimental: API optimization 7
Oral administration of pill with API, for PK optimization #7
Drug: Teriparatide
single oral tablet
Drug: Teriparatide
subcutaneous standard injection
Active Comparator: Teriparatide group 2
Subcutaneous injection of Teriparatide
Drug: Teriparatide
single oral tablet
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
Drug: Teriparatide
subcutaneous standard injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to 17 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Entera Bio Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0020-11-HMO-EnteraBio

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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