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

Primary Purpose

Growth Failure, Growth Hormone Deficiency

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
r-hGH liquid (Saizen)
r-hGH liquid (Saizen)
r-hGH freeze-dried
Sponsored by
EMD Serono
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Growth Failure focused on measuring Saizen®, bioequivalence, recombinant human, Growth Hormone, treatment of growth failure in children, growth hormone deficiency in adults

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • AAI Pharma Deutschland GmbH & Co. KG

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Secondary endpoints included further PK parameters.
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.

Full Information

First Posted
December 16, 2009
Last Updated
October 22, 2013
Sponsor
EMD Serono
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1. Study Identification

Unique Protocol Identification Number
NCT01034735
Brief Title
r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of the trial was to assess the bioequivalence for two concentrations (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH freeze-dried multidose formulation (Saizen® 8 mg, 8.8 mg/1.51 mL) as reference. Each volunteer received three r hGH treatments, with each treatment being administered as a single subcutaneous dose of 4 mg r-hGH in a randomized sequence with at least one week of wash-out period between successive treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Failure, Growth Hormone Deficiency
Keywords
Saizen®, bioequivalence, recombinant human, Growth Hormone, treatment of growth failure in children, growth hormone deficiency in adults

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Experimental
Arm Title
Arm C
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
r-hGH liquid (Saizen)
Intervention Description
Treatment Arm A: r-hGH liquid multidose formulation 5.83 mg/mL, needle injection (0.686 mL)
Intervention Type
Biological
Intervention Name(s)
r-hGH liquid (Saizen)
Intervention Description
Treatment Arm B: r-hGH liquid multidose formulation 8.0 mg/mL, needle injection (0.5 mL)
Intervention Type
Biological
Intervention Name(s)
r-hGH freeze-dried
Intervention Description
Treatment Arm C: r-hGH 8 mg (8.8 mg/1.51 ml) freeze-dried formulation ( reconstituted in metacresol 0.3% w/v) needle injection (0.686 mL)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Secondary endpoints included further PK parameters.
Time Frame
15 +/-3 days post last r hGH dose
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Main inclusion criteria: Male and female aged 18 to 45 years, inclusive; who are able to read, to write and to fully understand German language Had given written Informed Consent 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) 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 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 Were able to communicate well with the Investigator and willing to comply with the requirements of the entire trial Were willing to undergo pituitary down-regulation by intravenous infusion with somatostatin for 25 hours If female: Had a negative serum pregnancy test within three weeks prior to trial start and a negative urine pregnancy test at the day before dosing 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: 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 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 Had positive results for drugs of abuse or alcohol test 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 History or presence of hypertension or other significant cardiovascular abnormalities History or presence of cholelithiasis Significant history or clinical evidence of auto-immune, gastrointestinal, haematological, hematopoietic, hepatic, neurological, pancreatic or renal disease History or presence of diabetes History or presence of tumors of the pituitary gland or hypothalamus 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lissy, MD
Organizational Affiliation
AAIPharma Deutschland GmbH & Co. KG
Official's Role
Principal Investigator
Facility Information:
Facility Name
AAI Pharma Deutschland GmbH & Co. KG
City
Neu-Ulm
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20961422
Citation
Liedert B, Forssmann U, Wolna P, Golob M, Kovar A. Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation. BMC Clin Pharmacol. 2010 Oct 20;10:14. doi: 10.1186/1472-6904-10-14.
Results Reference
derived

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

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