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

NCT ID: NCT02202603

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-08-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Teriparatide group 1

Subcutaneous injection of Teriparatide

Group Type: ACTIVE_COMPARATOR

Teriparatide

Intervention Type: DRUG

subcutaneous standard injection

excipients

Oral pill without API

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Oral placebo

API

Oral administration of pill with API

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

single oral tablet

API optimization 1

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

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

single oral tablet

API optimization 2

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

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

single oral tablet

API optimization 3

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

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

single oral tablet

API optimization 4

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

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

single oral tablet

API optimization 5

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

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

single oral tablet

API optimization 6

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

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

single oral tablet

API optimization 7

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

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

single oral tablet

Teriparatide group 2

Subcutaneous injection of Teriparatide

Group Type: ACTIVE_COMPARATOR

Teriparatide

Intervention Type: DRUG

subcutaneous standard injection

Excipients

Oral pill without API

Group Type: EXPERIMENTAL

placebo

Intervention Type: DRUG

Oral placebo

API Optimized

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

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

single oral tablet

Interventions

Teriparatide

single oral tablet

Intervention Type: DRUG

Teriparatide

subcutaneous standard injection

Intervention Type: DRUG

placebo

Oral placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Entera Bio Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yosef Caraco, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Ein Kerem Medical Center

Locations

HMO Clinical Research Center Hadassah Ein Kerem Medical Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

0020-11-HMO-EnteraBio

Identifier Type: -

Identifier Source: org_study_id