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Phase 1 Study of Trastuzumab Administered as a Single Intravenous Infusion

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ClinicalTrials.gov Identifier: NCT02594761
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : November 3, 2015
Sponsor:
Collaborator:
Mylan GmbH
Information provided by (Responsible Party):
Mylan Pharmaceuticals

Brief Summary:
The primary objective of this study was to demonstrate pharmacokinetic similarity of Mylan trastuzumab (Hercules) versus EU-approved Herceptin® and US-licensed Herceptin® and pharmacokinetic similarity of EU-approved Herceptin® versus US-licensed Herceptin® after 8 mg/kg as single dose administered as intravenous infusion over 90 minutes in healthy male subjects based on the equivalence criterion that AUC0-∞, AUC0-last, and Cmax least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%. Three similarity assessments were performed, 1) Hercules vs. EU-approved Herceptin®, 2) Hercules vs. US-licensed Herceptin® and 3) EU-approved Herceptin® vs. US-licensed Herceptin®. Secondary objectives included further pharmacokinetic assessment of similarity of Hercules, EU-approved Herceptin® and US-licensed Herceptin® λz, tmax and t1/2 along with assessment of safety (including immunogenicity) and local tolerance.

Condition or disease Intervention/treatment Phase
Healthy Biological: Hercules Biological: Herceptin EU Biological: Herceptin US Phase 1

Detailed Description:
All subjects checked into the clinical facility on the day prior to dosing. On study day 1, each subject received either a single i.v. infusion of 8 mg/kg BW in 250 mL normal saline over a 90 minute period of Mylan trastuzumab (Hercules), EU-approved Herceptin®, or US-licensed Herceptin®. Dosing occurred following an overnight fast of at least 8 hours. On the day of dosing, subjects fasted for the first 3 hours after the start of the infusion then received standard meals approximately 3, 6 and 9 hours post-dose. In each study period, blood samples were collected just immediately prior to dose administration (0 hour) and at 45 and 90 minutes (just prior to end of infusion). Blood samples were collected post-dose at 3, 6, 9, 24 and 48 hours, relative to the start of infusion. The subjects were allowed to leave the clinical facility after the 48-hour blood sample collection. Subjects returned to the clinical facility for the scheduled blood sample collections post-dose on Day 5, 8, 11, 15, 22, 29, 43, 57, and 71. Serum samples were stored at −80°C ± 15°C until shipment for analysis. Blood samples for anti-drug antibodies (ADA) were collected prior to dosing on Day 1 and on Day 71. Blood samples for C-reactive protein (CRP) were obtained at Screening, prior to dosing and at 3, 24 and 48 hours post-dose and on Day 8 and 71. Blood samples for analysis of immunoglobulins were collected prior to dosing on Day 1 and on Day 8 and 71.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Pharmacokinetic Study Comparing Hercules, EU-approved Herceptin® and US-Licensed Herceptin® Administered as a Single Intravenous Infusion to Healthy Male Volunteers
Study Start Date : August 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: Treatment A
Hercules: 8 mg/kg i.v. infusion over 90 minutes
Biological: Hercules
Powder Concentrate for Intravenous Infusion, 150 mg/vial
Other Name: Trastuzumab

Active Comparator: Treatment B
Herceptin EU: 8 mg/kg i.v. infusion over 90 minutes
Biological: Herceptin EU
Powder for Concentrate for Solution for Infusion, 150 mg/vial
Other Name: Trastuzumab

Active Comparator: Treatment C
Herceptin US: 8 mg/kg i.v. infusion over 90 minutes
Biological: Herceptin US
Intravenous Infusion, 440 mg/vial
Other Name: Trastuzumab




Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: 71 days ]
    The primary pharmacokinetic variables for assessment of bioequivalence are dose-normalized Cmax based on the equivalence criterion that Cmax least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%.

  2. Area Under the Plasma Concentration Versus Time Curve (AUC) - Time 0 to Last Blood Draw (AUC0-last) [ Time Frame: 71 days ]
    The primary pharmacokinetic variables for assessment of bioequivalence are dose-normalized AUC0-last based on the equivalence criterion that AUC0-last least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%.

  3. Area Under the Plasma Concentration Versus Time Curve (AUC) - Time 0 to Infinity AUC0-∞) [ Time Frame: 71 days ]
    The primary pharmacokinetic variables for assessment of bioequivalence are dose-normalized AUC0-∞, based on the equivalence criterion that AUC0-∞ least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%.


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (AEs) [ Time Frame: 71 days ]
  2. Local Infusion Tolerance [ Time Frame: 71 days ]
  3. Immunogenicity [ Time Frame: 71 days ]
  4. Measurement of C-reactive Protein [ Time Frame: 71 days ]
  5. Monitoring of Heart Function (ECG and Echocardiography) [ Time Frame: 71 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adult subjects, age 18 to 55 years old
  • able to understand procedures, agree to participate and willing to give informed consent

Exclusion Criteria:

  • history of any significant disease
  • use of any medication 7 days prior to start of study
  • participation in a clinical trial within 30 days of start of study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594761


Sponsors and Collaborators
Mylan Pharmaceuticals
Mylan GmbH
Investigators
Principal Investigator: Apinya Vutikullird, D.O. WCCT Global

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mylan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02594761     History of Changes
Other Study ID Numbers: Myl-Her 1002
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Trastuzumab
Antineoplastic Agents