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| Name | Class |
|---|---|
| Teva Branded Pharmaceutical Products R&D, Inc. | INDUSTRY |
| TransPharma Medical | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hGH-ViaDermâ„¢ 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-ViaDermâ„¢ System | Device | The hGH-ViaDermâ„¢ System is a transdermal delivery system for somatropin (hGH, rDNA origin). The ViaDerm Systemâ„¢ 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-MicroChannelsâ„¢, 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 ViaDermâ„¢ device. hGH is delivered by passive diffusion through the RF-MicroChannelsâ„¢ into the systemic circulation system. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Noa Avisar, PhD | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| D001849 |
| Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |