Status:
COMPLETED
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
Lead Sponsor:
Altus Pharmaceuticals
Conditions:
Adult Growth Hormone Deficiency
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00297713
Start Date
July 1 2005
End Date
June 1 2006
Last Update
December 13 2006
Active Locations (3)
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1
University of Louisville
Louisville, Kentucky, United States, 40202
2
University of Texas Medical Branch
Galveston, Texas, United States, 77555
3
Diabetes and Glandular Disease Clinic
San Antonio, Texas, United States, 78229