Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety

Adult Growth Hormone Deficiency Clinical Trial

Official title:

A Phase II, Multi-Center, Multi-Dose, Randomized, Open-Label, Parallel Group Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297713
• Other study ID #: 230-00009
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2006
• Last updated: December 11, 2006
• Start date: July 2005
• Est. completion date: June 2006

Study information

• Verified date: December 2006
• Source: Altus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

ALTU-238 is a long acting crystalline formulation of recombinant human growth hormone (rhGH) that is being developed for the treatment of growth hormone deficiency in adults and children. ALTU-238 is designed to require fewer injections than the currently available formulations of rhGH.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Growth hormone deficient men and women ages 18-60 years with a hypothalamic and/or pituitary structural lesion or longstanding idiopathic GHD

• Growth hormone deficiency as determined by pituitary testing within the last five years by either of the two following tests:

1. Insulin hypoglycemia (glucose < 50 mg/dL) with maximum GH < 5 ng/mL (5 µg/L) by radioimmunoassay or < 2.5 µg/L, if measured by immunoradiometric assay

2. Arginine-GHRH infusions with maximum GH < 5 ng/mL (5 µg/L) or < 2.5 µg/L, if measured by immunoradiometric assay

• Women must be of non-child bearing potential (hysterectomy, tubal ligation, or IUD are acceptable) during the three months prior to entering the study, or post-menopausal (no menses for one year or more), or six to twelve months without menses and ß-estradiol levels < 20 pg/mL

• Glucocorticoid use is allowed provided the subject has been on physiologic (<7.5 mg prednisone or equivalent/day) replacement doses for at least 3 months

• Free thyroxine (T4) within the normal range at Screening. If the subject is receiving thyroid hormone replacement therapy, the dose must be stable for at least 6 weeks prior to Screening

• Willing and able to provide written informed consent

• BMI 20 - 36 kg/m2

Exclusion Criteria:

• Any previous or ongoing clinically significant illness that, in the opinion of the investigator, could prevent the subject from completing the study

• Any history of cancer within the past 5 years, except for dermal squamous and basal cell carcinoma with documented 6-month remission. Subjects with a more recent history of successfully treated cervical carcinoma in situ will not be excluded provided there is documented 12-month remission

• BMI <20 or >36 kg/m2

• Any allergic or abnormal reaction to human growth hormone

• Inability of the subject to discontinue use of their regularly prescribed human growth hormone treatment from six weeks prior to Day -1 through the completion of the study

• Serum creatinine > 1.4 mg/dL

• Hypocalcemia or hypercalcemia from any cause

• Hyperparathyroidism, osteomalacia or any other disorder which may affect bone and bone markers including the use of bisphosphonates or other medications for osteoporosis

• Participation in another clinical trial 30 days prior to screening

• Demonstrated inability to comply with protocol requirements (e.g. uncooperative attitude, inability to return for follow-up visits, history of medical non-compliance, and/or poor likelihood of completing the study)

• Blood donation within 56 days of the screening visit

• Plasma donation within seven days of the screening visit

• Positive serum pregnancy test

• Women of child bearing potential

• Abuse of alcohol; to be determined by principal investigator

• Abuse of prescription or illicit drugs; to be determined by principal investigator

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary

Intervention

Drug:
• ALTU-238

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas
United States	University of Louisville	Louisville	Kentucky
United States	Diabetes and Glandular Disease Clinic	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Altus Pharmaceuticals

Country where clinical trial is conducted

United States,