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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

This study has been completed.
Sponsor:
Information provided by:
Altus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00297713
First received: February 27, 2006
Last updated: December 11, 2006
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Adult Growth Hormone Deficiency
Drug: ALTU-238
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Altus Pharmaceuticals:

Estimated Enrollment: 12
Study Start Date: July 2005
Estimated Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 β-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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297713

Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Altus Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00297713     History of Changes
Other Study ID Numbers: 230-00009
Study First Received: February 27, 2006
Last Updated: December 11, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Endocrine System Diseases
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014