A Multi-Dose Study to Assess Tolerability, Safety and Pharmacology of hGH-ViaDerm™ System in Adults With GH-Deficiency

August 30, 2013 updated by: Teva Neuroscience, Inc.

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study, to Assess Tolerability, Safety, Pharmacokinetic and Pharmacodynamic Profiles of hGH-ViaDerm™ System in Adult Subjects With Growth Hormone Deficiency

This study aims to examine the safety, tolerability and pharmacokinetics of transdermal delivery of human Growth Hormone (hGH or somatropin) using the ViaDerm device in adult patients with Growth Hormone Deficiency Syndrome.

Study Overview

Status

Completed

Conditions

Growth Hormone Deficiency

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

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

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Ages Eligible for Study: 20 Years - 60 Years, Genders Eligible for Study: Both

Clinical diagnosis of Adult Growth Hormone Deficiency (AGHD) meeting one of the following criteria:
- Three or more additional pituitary hormone deficiencies, based on well documented medical history from up to 10 years prior to screening, and/or serum IGF-1 levels below 2 SD from normal level, measured up to 4 months prior to screening.
- One or two additional pituitary hormone deficiencies with one GH stimulating test performed within 10 years prior to screening: Insulin Tolerance test with GH levels less than 5.1 µg/L or ARG-GHRH with GH levels less than 4.1 µg/L.
- Isolated GH deficient subjects with two well-documented GH stimulating tests performed within 10 years prior to screening. Insulin Tolerance test with GH levels less than 5.1 µg/L or ARG-GHRH with GH levels less than 4.1 µg/L.
- In childhood onset AGHD, confirmation of GHD following attainment of full height.
Subjects using hormone replacement therapy for additional pituitary deficits must be on an optimized treatment regimen for at least three months prior to screening.
Willing and able to provide written informed consent prior to performing any study procedures.

Exclusion Criteria:

GH therapy within one month prior to study entry.
For female subjects: pregnancy or lactation or use of oral contraception or unacceptable method of contraception throughout the study.
Active acromegaly in the last 5 years.
Carpal tunnel syndrome.
Prader-Willi syndrome.
Active Cushing's syndrome within the last 12 months.
Non-compliance for upper arm SC injection or patch application.
Skin color or tattoo that would not enable detection of erythema.
Upper extremities with skin marks, bruises, cuts, abrasions on the upper arm.
Dense and dark hair growth on upper extremities.
History of skin hypersensitivity and/or allergies.
Known hypersensitivity to somatropin or mannitol
Evidence of active malignancy.
Previous use of chemotherapy, immunosuppressive or radiation therapy, except for treatment of pituitary disease.
Serum glucose (fasting) > 126 mg/dl.
Known or suspected HIV-positive subjects or subjects with advanced diseases such as AIDS, Hepatitis C, Hepatitis B or tuberculosis.
Subjects who, based on the investigator's judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Conditions may include cardiovascular, vascular, pulmonary, hepatic, renal, or neurological disease, as determined by medical history, physical examination, laboratory tests or ECG.
BMI < 19 and ≥ 35 kg/m2.
Weight reducing drugs or appetite suppressants.
Estrogen replacement therapy except transdermal patch.
Any psychological condition which may influence the compliance with the study requirements.
Unstabilized antidepressant or antipsychotic medication therapy within 2 months prior to screening.
Subjects with a known history of alcohol abuse.
Subjects who received blood or plasma derivatives in the three months preceding screening.
Subjects who donated blood in the preceding three months of screening or intend to make a blood donation during the study, or within the three months following the study completion.
Subjects who have participated in another clinical study of any kind (drug or device) in the one month prior to screening.
Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.

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 Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AE Time Frame: 36 days	36 days
Laboratory values Time Frame: 36 days	36 days
Vital signs Time Frame: 36 days	36 days
ECG Time Frame: 36 days	36 days
Patch application site reaction: Skin irritation- erythema, edema Time Frame: 36 days	36 days
Patch application site reaction: Pain - Visual Analogue Scale Time Frame: 36 days	36 days
Proportion of subjects (%) who discontinue the study Time Frame: 36 days	36 days
Proportion of subjects (%) who discontinue the study due to AEs Time Frame: 36 days	36 days
Pharmacokinetics: Somatropin exposure including Cmax, Tmax, AUC, AUC, Ke, and T1/2. Time Frame: 36 days	36 days
Pharmacodynamics: Human IGF-1 levels and AUC. Time Frame: 36 days	36 days

Collaborators and Investigators

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

Sponsor

Teva Neuroscience, Inc.

Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.

TransPharma Medical

Investigators

Study Director: Noa Avisar, PhD, Teva Branded Pharmaceutical Products R&D, Inc.

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

April 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

April 2, 2007

First Submitted That Met QC Criteria