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

Altus Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Adult Growth Hormone Deficiency

Treatments

Drug: ALTU-238

Study type

Interventional

Funder types

Industry

Identifiers

NCT00297713

230-00009

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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