Drug SafetyPhase 1NCT02202603
A Three Stage, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in Healthy Subjects
A Phase 1 study testing Teriparatide in people with Drug Safety, run by Entera Bio Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Safety
- What is being tested?
- Teriparatide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Aug 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ● 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.
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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 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
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
HMO Clinical Research Center Hadassah Ein Kerem Medical Center
Jerusalem, 91120,
About this study
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.
Read the 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)
- Conditions
- Drug Safety
- Being tested
- Teriparatide, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
single oral tablet
TeriparatideDrug
subcutaneous standard injection
placeboDrug
Oral placebo
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide group 1 | Active comparator | Subcutaneous injection of Teriparatide Receives: Drug: Teriparatide |
| excipients | Placebo comparator | Oral pill without API Receives: Drug: placebo |
| API | Experimental | Oral administration of pill with API Receives: Drug: Teriparatide |
| API optimization 1 | Experimental | Oral administration of pill with API, for PK optimization #1 Receives: Drug: Teriparatide |
| API optimization 2 | Experimental | Oral administration of pill with API, for PK optimization #2 Receives: Drug: Teriparatide |
| API optimization 3 | Experimental | Oral administration of pill with API, for PK optimization #3 Receives: Drug: Teriparatide |
| API optimization 4 | Experimental | Oral administration of pill with API, for PK optimization #4 Receives: Drug: Teriparatide |
| API optimization 5 | Experimental | Oral administration of pill with API, for PK optimization #5 Receives: Drug: Teriparatide |
| API optimization 6 | Experimental | Oral administration of pill with API, for PK optimization #6 Receives: Drug: Teriparatide |
| API optimization 7 | Experimental | Oral administration of pill with API, for PK optimization #7 Receives: Drug: Teriparatide |
| Teriparatide group 2 | Active comparator | Subcutaneous injection of Teriparatide Receives: Drug: Teriparatide |
| Excipients | Experimental | Oral pill without API Receives: Drug: placebo |
| API Optimized | Experimental | expanded group size with API in optimized dosage and administration form. Receives: Drug: Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: up to 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startJul 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug SafetyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entera Bio Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yosef Caraco, MD, Principal investigator, Hadassah Ein Kerem Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202603
- Sponsor's protocol ID
- 0020-11-HMO-EnteraBio
- Status last verified
- Oct 2015
- First submitted
- 20 Jun 2011
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three Stage, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02202603
- Acronym / sponsor ID
- 0020-11-HMO-EnteraBio
- Conditions
- Drug Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Entera Bio Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 Jul 2014 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Teriparatide group 1 | Active comparator | Drug: TeriparatideSubcutaneous injection of Teriparatide |
| excipients | Placebo comparator | Drug: placeboOral pill without API |
| API | Experimental | Drug: TeriparatideOral administration of pill with API |
| API optimization 1 | Experimental | Drug: TeriparatideOral administration of pill with API, for PK optimization #1 |
| API optimization 2 | Experimental | Drug: TeriparatideOral administration of pill with API, for PK optimization #2 |
| API optimization 3 | Experimental | Drug: TeriparatideOral administration of pill with API, for PK optimization #3 |
| API optimization 4 | Experimental | Drug: TeriparatideOral administration of pill with API, for PK optimization #4 |
| API optimization 5 | Experimental | Drug: TeriparatideOral administration of pill with API, for PK optimization #5 |
| API optimization 6 | Experimental | Drug: TeriparatideOral administration of pill with API, for PK optimization #6 |
| API optimization 7 | Experimental | Drug: TeriparatideOral administration of pill with API, for PK optimization #7 |
| Teriparatide group 2 | Active comparator | Drug: TeriparatideSubcutaneous injection of Teriparatide |
| Excipients | Experimental | Drug: placeboOral pill without API |
| API Optimized | Experimental | Drug: Teriparatideexpanded group size with API in optimized dosage and administration form. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- ● Signed Informed consent to the study.
Key exclusion criteria (10 listed)
- ● Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
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 |
|---|---|---|
| Teriparatidesingle oral tablet | Drug | API, API Optimized, API optimization 1, API optimization 2, API optimization 3, API optimization 4, API optimization 5, API optimization 6, API optimization 7 |
| Teriparatidesubcutaneous standard injection | Drug | Teriparatide group 1, Teriparatide group 2 |
| placeboOral placebo | Drug | Excipients, excipients |
Primary outcome
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
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 7 Oct 2015.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Teriparatide in people with Drug Safety, run by Entera Bio Ltd. at 1 site in Israel.
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 10 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 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Adverse events (time frame: up to 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.