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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00297713
• Date of registration: 27/02/2006
• Prospective Registration: No
• Primary sponsor: Altus Pharmaceuticals
• Public title: 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
• Scientific 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
• Date of first enrolment: July 2005
• Target sample size: 12
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00297713
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Adult Growth Hormone Deficiency

Intervention(s)

Drug: ALTU-238

Secondary ID(s)

230-00009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors