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

NCT00455260 | Completed Phase 1

• 1 other identifier: GH-VD-102
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (10)

• AE

  36 days

• Laboratory values

  36 days

• Vital signs

  36 days

• ECG

  36 days

• Patch application site reaction: Skin irritation- erythema, edema

  36 days

• Patch application site reaction: Pain - Visual Analogue Scale

  36 days

• Proportion of subjects (%) who discontinue the study

  36 days

• Proportion of subjects (%) who discontinue the study due to AEs

  36 days

• Pharmacokinetics: Somatropin exposure including Cmax, Tmax, AUC, AUC, Ke, and T1/2.

  36 days

• Pharmacodynamics: Human IGF-1 levels and AUC.

  36 days

Interventions

hGH-ViaDerm™ System (hGH or somatropin) DRUG

transdermal patch; Group 1: 0.2 mg/day SC hGH during Period I, and 0.5 mg per transdermal patch during Period III (expected equivalent dose to SC 0.2 mg/day) Group 2: 0.4 mg/day SC hGH during Period I, and 2.0 mg per transdermal patch during Period III (expected equivalent dose to SC 0.4 mg/day) Group 3: 1.0 mg/day SC hGH during Period I, and 5.0 mg per transdermal patch during Period III (expected equivalent dose to 1.0 mg/day)

hGH-ViaDerm™ System DEVICE

The hGH-ViaDerm™ System is a transdermal delivery system for somatropin (hGH, rDNA origin). The ViaDerm System™ consists of a medical device component and a printed dry hGH patch component. The device component is comprised of two primary elements: a reusable, computer mouse-like electronic controller and a disposable sterile array, which is inserted onto the base of the controller, delivers RF-current to ablate cells and creates microscopic throughways, termed RF-MicroChannels™, across the stratum corneum into the upper epidermis. The drug component consists of a unique circular transdermal dry hGH patch formulated specifically for use with the ViaDerm™ device. hGH is delivered by passive diffusion through the RF-MicroChannels™ into the systemic circulation system.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Neuroscience, Inc.: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator
• TransPharma Medical: collaborator

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Noa Avisar, PhD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 2, 2007
• First Posted: April 3, 2007
• Study Start: April 1, 2007
• Primary Completion: October 1, 2007
• Last Updated: September 2, 2013

Record last verified: 2009-04