NCT02594761

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2013

Typical duration for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

6 months

First QC Date

October 29, 2015

Last Update Submit

October 30, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Peak Plasma Concentration (Cmax)

    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%.

    71 days

  • Area Under the Plasma Concentration Versus Time Curve (AUC) - Time 0 to Last Blood Draw (AUC0-last)

    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%.

    71 days

  • Area Under the Plasma Concentration Versus Time Curve (AUC) - Time 0 to Infinity AUC0-∞)

    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%.

    71 days

Secondary Outcomes (5)

  • Incidence of Treatment-Emergent Adverse Events (AEs)

    71 days

  • Local Infusion Tolerance

    71 days

  • Immunogenicity

    71 days

  • Measurement of C-reactive Protein

    71 days

  • Monitoring of Heart Function (ECG and Echocardiography)

    71 days

Study Arms (3)

Treatment A

EXPERIMENTAL

Hercules: 8 mg/kg i.v. infusion over 90 minutes

Biological: Hercules

Treatment B

ACTIVE COMPARATOR

Herceptin EU: 8 mg/kg i.v. infusion over 90 minutes

Biological: Herceptin EU

Treatment C

ACTIVE COMPARATOR

Herceptin US: 8 mg/kg i.v. infusion over 90 minutes

Biological: Herceptin US

Interventions

HerculesBIOLOGICAL

Powder Concentrate for Intravenous Infusion, 150 mg/vial

Also known as: Trastuzumab
Treatment A
Herceptin EUBIOLOGICAL

Powder for Concentrate for Solution for Infusion, 150 mg/vial

Also known as: Trastuzumab
Treatment B
Herceptin USBIOLOGICAL

Intravenous Infusion, 440 mg/vial

Also known as: Trastuzumab
Treatment C

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Waller CF, Vutikullird A, Lawrence TE, Shaw A, Liu MS, Baczkowski M, Sharma R, Barve A, Goyal P, Donnelly C, Sengupta N, Pennella EJ. A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL-1401O vs. EU-trastuzumab and US-trastuzumab. Br J Clin Pharmacol. 2018 Oct;84(10):2336-2343. doi: 10.1111/bcp.13689. Epub 2018 Jul 31.

    PMID: 29926514DERIVED

MeSH Terms

Interventions

hercules receptor kinase 2, ArabidopsisTrastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Apinya Vutikullird, D.O.

    WCCT Global

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 3, 2015

Study Start

August 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 3, 2015

Record last verified: 2015-10