r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01034735
• Date of registration: 16/12/2009
• Prospective Registration: No
• Primary sponsor: EMD Serono
• Public title: r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial
• Scientific title: Phase I, Open Label, Randomised Three-way Cross Over, Single-centre Trial to Assess the Bioequivalence for Two Concentrations of the New r-hGH Liquid Multidose Formulation Versus the r-hGH Freeze-dried Multidose Formulation Administered in Healthy Volunteers
• Date of first enrolment: July 2008
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01034735
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Michael Lissy, MD
• Affiliation: AAIPharma Deutschland GmbH & Co. KG

Key inclusion & exclusion criteria

Inclusion Criteria:

Main inclusion criteria:

1. Male and female aged 18 to 45 years, inclusive; who are able to read, to write and to
fully understand German language

2. Had given written Informed Consent

3. Had a body weight greater than 55 kg and a body mass index (BMI) of >20 and < or =
30 kg/m2 (BMI = weight (kg)/height (m)2)

4. Had vital signs in the following normal range:

Ear body temperature: 35.0 - 38.0°C

Blood pressure (BP) - after at least 3 minutes of rest, measured in the supine
position:

systolic blood pressure: 90 - 145 mmHg diastolic blood pressure : 50 - 95 mmHg Pulse
rate (PR): after at least 3 minutes of rest, measured in the supine position: 40 90
bpm

5. Smoked less than 10 cigarettes per day, consented to smoke less than 5 cigarettes per
day during the trial period and were able to refrain from smoking during the
confinement period

6. Were able to communicate well with the Investigator and willing to comply with the
requirements of the entire trial

7. Were willing to undergo pituitary down-regulation by intravenous infusion with
somatostatin for 25 hours

If female:

8. Had a negative serum pregnancy test within three weeks prior to trial start and a
negative urine pregnancy test at the day before dosing

9. Were pre-menopausal and using an adequate method of non-hormonal contraception (2
barrier methods, or one barrier method with spermicide, or non-hormonal intrauterine
device), sexual abstinence or females with vasectomised partners during the entire
trial

Exclusion Criteria:

Main exclusion criteria:

1. Any surgical or medical condition, including findings in the medical history or in
the pre trial assessments, that in the opinion of the Investigator, constituted a
risk or a contraindication for the participation of the subject in the trial or that
could have interfered with the trial objectives, conduct or evaluation

2. Had any clinically significant abnormal laboratory test results in the pre-trial
safety laboratory tests or any clinically abnormal findings on the 12 leads resting
electrocardiogram (ECG) that in the opinion of the Investigator may have increased
the safety risk to the subject

3. Had positive results for drugs of abuse or alcohol test

4. Had positive results from serology examination for Hepatitis B surface antigen
(HBsAg) (not due to vaccination), Hepatitis B core antibody (HBcAb) (if positive, was
to be verified by test for anti-Hbc-IgM), Hepatitis C Virus (anti-HCV) and Human
Immunodeficiency Virus (anti-HIV 1 and 2) at screening

5. History or presence of hypertension or other significant cardiovascular abnormalities

6. History or presence of cholelithiasis

7. Significant history or clinical evidence of auto-immune, gastrointestinal,
haematological, hematopoietic, hepatic, neurological, pancreatic or renal disease

8. History or presence of diabetes

9. History or presence of tumors of the pituitary gland or hypothalamus

10. Definite or suspected personal history or family history of adverse drug reaction or
hypersensitivity to drugs with a similar chemical structure to somatropin or
somatostatin or its excipients, use of any chronic medication



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Growth Failure

Intervention(s)

Biological: r-hGH freeze-dried

Biological: r-hGH liquid (Saizen)

Primary Outcome(s)

Primary endpoints were the pharmacokinetic (PK) parameters of r-hGH: the area under the serum concentration-time curve from time zero to last detectable serum concentration (AUC0 t) and the maximum observed serum concentration (Cmax). [Time Frame: 24 hours post r hGH dose]

Secondary Outcome(s)

Safety and tolerability were evaluated by adverse events (AEs), medical history, physical examination, vital signs, local tolerability, visual analog scale (VAS), ECG recordings, glycemia measurements and laboratory tests. [Time Frame: 15 +/-3 days post last r hGH dose]

Secondary endpoints included further PK parameters. [Time Frame: 15 +/-3 days post last r hGH dose]

Secondary ID(s)

28798

Source(s) of Monetary Support

Please refer to primary and secondary sponsors