Drug Safety and BioavailabilityPhase 1NCT02571140

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

A Phase 1 study testing Teriparatide and Oral PTH (1-34) in people with Drug Safety and Bioavailability, run by Entera Bio Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Drug Safety and Bioavailability
What is being tested?: Teriparatide and Oral PTH (1-34)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: Oct 2013to Oct 2017
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Signed Informed consent to the study.
Males ,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.

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Negative serology to HIV, Hepatitis B, Hepatitis C.
No known drug and alcohol abuse
Negative urinary drugs of abuse at screening
No sensitivity to dairy products
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

Who cannot join

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.

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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

About this study

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

Conditions: Drug Safety and Bioavailability
Being tested: Teriparatide, Oral PTH (1-34)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TeriparatideDrug
subcutaneous standard injection
Oral PTH (1-34)Drug
Also called Teriparatide
Different optimization of API

Study groups in NCT02571140
Study group	Role	What they receive
Active Comparator	Active comparator	Subcutaneous injection of Teriparatide Receives: Drug: Teriparatide
Oral PTH (1-34)	Experimental	Oral administration of pill with API with different optimizations Receives: Drug: Oral PTH (1-34)

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Plasma Concentration
Blood samples for determination of PTH plasma concentrations will be taken at the time points to study the pharmocokinetc profile
Measured: 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
Measured: 60-522 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Oct 2017

First posted8 Oct 2015 (estimated)
Study startOct 2013
Primary completionAug 2017
Study completionOct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Drug Safety and BioavailabilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02571140
Sponsor's protocol ID: ENT-02-2013
Status last verified: Jan 2018
First submitted: 6 Oct 2015
Last updated: 10 Jan 2018
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects
ClinicalTrials.gov ID: NCT02571140
Acronym / sponsor ID: ENT-02-2013
Conditions: Drug Safety and Bioavailability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Entera Bio Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Aug 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 8 Oct 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Active Comparator	Active comparator	Drug: TeriparatideSubcutaneous injection of Teriparatide
Oral PTH (1-34)	Experimental	Drug: Oral PTH (1-34)Oral administration of pill with API with different optimizations

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (15 listed)

Signed Informed consent to the study.
Males ,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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Teriparatidesubcutaneous standard injection	Drug	Active Comparator
Oral PTH (1-34)Also: TeriparatideDifferent optimization of API	Drug	Oral PTH (1-34)

Primary outcome

Peak Plasma Concentration
Time frame: 60-522 days
Blood samples for determination of PTH plasma concentrations will be taken at the time points to study the pharmocokinetc profile

1 secondary outcome

Adverse Events
Time frame: 60-522 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yosef Caraco, MD principal investigator

Hadassah Ein Kerem Medical Center

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Teriparatide and Oral PTH (1-34) in people with Drug Safety and Bioavailability, run by Entera Bio Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (time frame: 60-522 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02571140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.