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

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

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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

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

 Secondary endpoints included further PK parameters.

Condition

Growth Failure

Intervention

r-hGH liquid (Saizen)

Study Arms / Comparison Groups

 Arm A

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

30

Start Date

July 2008

Primary Completion Date

August 2008

Eligibility 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
      

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Michael Lissy, MD, , 

Location Countries

Germany

Location Countries

Germany

NCT ID

NCT01034735

Organization ID

28798

Responsible Party

Sponsor

Study Sponsor

EMD Serono

Study Sponsor

Michael Lissy, MD, Principal Investigator, AAIPharma Deutschland GmbH & Co. KG

Verification Date

October 2013