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

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Brief 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

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

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.
    


Study Phase

Phase 2

Study Type

Interventional




Condition

Adult Growth Hormone Deficiency

Intervention

ALTU-238


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

July 2005

Completion Date

June 2006


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
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00297713

Organization ID

230-00009



Study Sponsor

Altus Pharmaceuticals


Study Sponsor

, , 


Verification Date

December 2006