Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency

• Status: Completed
• Trial end date: 2016-11-29
• Target enrollment: 0
• Participant gender: All

Summary

The Macimorelin Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, 2-way crossover Trial. The trial will include subjects suspected to have adult growth hormone deficiency (AGHD) and a group of healthy control subjects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AEterna Zentaris
• Treatments: Hormones; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Suspected growth hormone deficiency (GHD), based on either of the following:

• structural hypothalamic or pituitary disease, or

• surgery or irradiation in these areas, or

• head trauma as an adult, or

• evidence of other pituitary hormone deficiencies, or

• idiopathic childhood onset GHD (without known hypothalamic or pituitary lesion or injury).

• Healthy* control subjects, matching a 'high likelihood GHD' subjects

Exclusion Criteria:

• GH therapy within 1 month prior to anticipated first GHST within this trial (within 3 months in case of long-acting GH formulation).

• GHST within 7 days prior to the anticipated first test day within the trial.

• Subjects with a medical history and clinical signs of a not adequately treated thyroid dysfunction or subjects who had a change in thyroid therapy within 30 days prior to anticipated first test day within the trial.

• Untreated hypogonadism or not on a stable substitution treatment within 30 days prior to anticipated first test day within the trial.

• Treatment with drugs directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levodopa, and dopamine agonists) or provoking the release of somatostatin; antimuscarinic agents (atropine).

• Concomitant use of a CYP3A4 inducer (e.g., carbamazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John's Wort).

• Medical history of ongoing clinically symptomatic severe psychiatric disorders.

• Parkinson's disease.

• Cushing disease or patients on supraphysiologic glucocorticoid therapy within 30 days prior to the anticipated first test day within the trial.

• Type 1 diabetes or untreated or poorly controlled Type 2 diabetes, as defined by HbA1c > 8%.

• Body mass index (BMI) ≥ 40.0 kg/m2.

• Participation in a trial with any investigational drug within 30 days prior to trial entry.

• Vigorous physical exercise within 24 hours prior to each GHST within this trial.

• Known hypersensitivity to macimorelin or insulin, or any of the constituents of either preparation.

• Clinically significant cardiovascular or cerebrovascular disease.

• Prolonged ECG QT interval, defined as corrected QT interval (QTc) > 500 msec.

• Concomitant treatment with any drugs that might prolong QT/QTc.

• Elevation of laboratory parameters indicating hepatic or renal dysfunction or damage (aspartate amino transferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyl transpeptidase (GGT)> 2.5 x ULN; ), creatinine, or bilirubin > 1.5x ULN).

• Medical history of seizure disorders.

• Known immunosuppression.

• Current active malignancy other than non-melanoma skin cancer.

• Breastfeeding or positive urine pregnancy test (for women of childbearing potential only).

• Women of childbearing age without contraception, such as hormonal contraception or use of condom and spermicides or use of diaphragm and spermicides or Intra Uterine Device (IUD).

• Lack of ability or willingness to give informed consent.

• Anticipated non-availability for trial visits/procedures.