Clinical trial NCT00297713: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult Growth Hormone Deficiency
Lead sponsor: Altus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-03-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Clinic
state: Texas
Study officials:
References: