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

NCT02202603 | Completed Phase 1 DMC

• 1 other identifier: 0020-11-HMO-EnteraBio
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Safety

Outcome Measures

Primary 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

  up to 17 weeks

Study Arms (13)

Teriparatide group 1

ACTIVE COMPARATOR

Subcutaneous injection of Teriparatide

Drug: Teriparatide

excipients

PLACEBO COMPARATOR

Oral pill without API

Drug: placebo

API

EXPERIMENTAL

Oral administration of pill with API

Drug: Teriparatide

API optimization 1

EXPERIMENTAL

Oral administration of pill with API, for PK optimization #1

Drug: Teriparatide

API optimization 2

EXPERIMENTAL

Oral administration of pill with API, for PK optimization #2

Drug: Teriparatide

API optimization 3

EXPERIMENTAL

Oral administration of pill with API, for PK optimization #3

Drug: Teriparatide

API optimization 4

EXPERIMENTAL

Oral administration of pill with API, for PK optimization #4

Drug: Teriparatide

API optimization 5

EXPERIMENTAL

Oral administration of pill with API, for PK optimization #5

Drug: Teriparatide

API optimization 6

EXPERIMENTAL

Oral administration of pill with API, for PK optimization #6

Drug: Teriparatide

API optimization 7

EXPERIMENTAL

Oral administration of pill with API, for PK optimization #7

Drug: Teriparatide

Teriparatide group 2

ACTIVE COMPARATOR

Subcutaneous injection of Teriparatide

Drug: Teriparatide

Excipients

EXPERIMENTAL

Oral pill without API

Drug: placebo

API Optimized

EXPERIMENTAL

expanded group size with API in optimized dosage and administration form.

Drug: Teriparatide

Interventions

Teriparatide DRUG

single oral tablet

API; API Optimized; API optimization 1; API optimization 2; API optimization 3; API optimization 4; API optimization 5; API optimization 6; API optimization 7

placebo DRUG

Oral placebo

Excipients; excipients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ● 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
• 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

You may not qualify if:

• ● 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.

Sponsors & Collaborators

• Entera Bio Ltd.: lead

Study Sites (1)

HMO Clinical Research Center Hadassah Ein Kerem Medical Center

Jerusalem, 91120,, Israel

Location

MeSH Terms

Interventions

Teriparatide

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Yosef Caraco, MD

  Hadassah Ein Kerem Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: July 29, 2014
• Study Start: July 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

IL (1)