A Long Acting Growth Hormone (Somavaratan) clinical study in adults to determine effective dose.

Phase 1

• Conditions: Growth Hormone Deficiency in adults; MedDRA version: 18.1Level: PTClassification code 10056438Term: Growth hormone deficiencySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-002072-24-DE
• Lead Sponsor: Versartis Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-12
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Female or male subjects with age 23 to 70 years (inclusive).
2. Female subjects of childbearing potential must agree to use appropriate contraceptive methods during the study and continue this method for at least one month after their study completion.
3. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening.
4. Subjects must have a documented medical history of GHD during adulthood, according to established guidelines (confirmatory testing
should be done to document persistence of childhood onset GHD into adulthood if necessary). Acceptable diagnostic criteria include:
- insulin tolerance test (ITT): peak hGH = 5.0 ng/mL
- arginine alone: peak hGH = 1.4 ng/mL
- arginine + growth-hormone-releasing hormone
- glucagon stimulation test: peak hGH = 3.0 ng/mL
OR
- at least 3 pituitary hormone deficiencies and a low IGF-I for age/gender

For arginine + GHRH stimulation test, peak hGH limit is based upon body mass index as follows: = 11.0 ng/mL for BMI < 25 kg/m2; = 8.0 ng/mL for 25 = BMI < 30 kg/m2; = 4.0 ng/mL for BMI = 30 kg/m2.
Current height may be used to determine BMI if BMI is not available from the date of the stimulation test.
If documented confirmation is not available, GH stimulation test may be performed at Screening (subjects receiving daily rhGH therapy must be withdrawn for at least 7 days prior to testing).
5. Subjects taking other hormone replacement therapy for pituitary failure must have been on a stable course of treatment for at least 3 months prior to Screening.
6. Subjects with underlying disorders responsible for the subject's GHD must have been clinically stable for at least 6 months prior to Screening.
7. If a subject is currently receiving daily recombinant human growth hormone (rhGH) injections for treatment of GHD, must agree to stop taking prescribed daily rhGH therapy for the washout period of 14 days minimum.
8. Subjects must agree to inform the prescribing physician of study involvement, and the Investigator, prior to initiating a new medication (prescription or over-the-counter).
9. Subjects must provide signed informed consent.
10. Subjects must have a BMI (kg/m2) between 19.0 and 35.0 (inclusive).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1.Subjects with a documented history of diabetes mellitus or inadequate glucose control as defined by a historical or Screening value of:
•FPG > 126 mg/dL (7 mM), or
•HbA1c = 6.5%
2.Subjects with untreated adrenal insufficiency. Adrenal insufficiency will be screened by morning serum cortisol followed by ACTH stimulation test for subjects without documented history of adrenal insufficiency.
3.Subjects with free thyroxine outside the normal reference range.
4.Subjects currently taking oral glucocorticoids, except for physiological maintenance doses of oral glucocorticoids in subjects with multiple pituitary hormone deficiencies.
5.Subjects with current significant cardiovascular disease, heart insufficiency of NYHA class > 2.
6.Subjects with current significant cerebrovascular, pulmonary, neurological (not considered related to GHD), renal, inflammatory, or hepatobiliary disease.
7.Subjects with current papilledema.
8.Subjects with a history of persistent (unresolved without medical intervention) or recurring migraines.
9.Subjects with current edema (= CTCAE Grade 2).
10.Subjects with current drug or alcohol abuse.
11.Subjects with a documented history of HIV, current HBV or HCV infection (testing not required).
12.Subjects with a prior history of malignancy or abnormal results of any routine cancer screening tests, excluding adequately treated non-melanoma skin cancers or adequately treated in situ carcinoma of the cervix.
13.Women who are pregnant or breastfeeding.
14.Subjects treated with an investigational drug within 30 days prior to Screening.
15.Subjects with a significant abnormality in Screening laboratory results as interpreted by the Investigator and/or the Medical Monitor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified