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

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

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.

Study Overview

• Status: Completed
• Conditions: Adult Growth Hormone Deficiency
• Intervention / Treatment: Drug: ALTU-238

• Study Type: Interventional
• Enrollment: 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • San Antonio, Texas, United States, 78229
      • Diabetes and Glandular Disease Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Collaborators and Investigators

• Sponsor: Altus Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Study Completion: June 1, 2006

Study Registration Dates

• First Submitted: February 27, 2006
• First Submitted That Met QC Criteria: February 27, 2006
• First Posted (ESTIMATE): March 1, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): December 13, 2006
• Last Update Submitted That Met QC Criteria: December 11, 2006
• Last Verified: December 1, 2006

More Information

Terms related to this study

• Other Study ID Numbers: 230-00009