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A Bioequivalence Study of Pegylated Interferon Alfa-2a (PEG-IFN Alfa-2a) Benzyl Alcohol (BA)-Free Formulation Versus PEG-IFN Alfa-2a (Pegasys) Following Subcutaneous Administration

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ClinicalTrials.gov Identifier: NCT02573025
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is an open-label, randomized, multi-center, single dose, two-period, two-sequence crossover study to investigate the bioequivalence of PEG-IFN alfa-2a BA-free formulation versus the reference market formulation (PEG-IFN alfa-2a [Pegasys®]) following subcutaneous administration via prefilled syringe in healthy Chinese participants.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: PEG-IFN alfa-2a BA-free formulation (Test) Drug: PEG-IFN alfa-2a market formulation (Reference) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Randomized, Multi-Center, Single Dose, Two-Period, Two Sequence Crossover Study to Investigate the Bioequivalence of Peginterferon (PEG-IFN) Alfa-2a Benzyl Alcohol-Free Formulation Versus the Reference Market Formulation Following Subcutaneous Administration Via Prefilled Syringe in Healthy Chinese Subjects
Actual Study Start Date : September 17, 2015
Actual Primary Completion Date : April 11, 2016
Actual Study Completion Date : April 11, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test Followed by Reference
Participants will receive PEG-IFN alfa-2a BA-free formulation (Test) in Period 1, followed by PEG-IFN alfa-2a market formulation (Reference) in Period 2 on Day 1 of each period with a washout period of 14 to 21 days.
Drug: PEG-IFN alfa-2a BA-free formulation (Test)
Participants will receive single injection of 180 micrograms (mcg) of PEG-IFN alfa-2a BA-free formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).

Drug: PEG-IFN alfa-2a market formulation (Reference)
Participants will receive single injection of 180 mcg of PEG-IFN alfa-2a market formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).
Other Name: Pegasys

Experimental: Reference Followed by Test
Participants will receive PEG-IFN alfa-2a market formulation (Reference) in Period 1, followed by PEG-IFN alfa-2a BA-free formulation (Test) in Period 2 on Day 1 of each period with a washout period of 14 to 21 days.
Drug: PEG-IFN alfa-2a BA-free formulation (Test)
Participants will receive single injection of 180 micrograms (mcg) of PEG-IFN alfa-2a BA-free formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).

Drug: PEG-IFN alfa-2a market formulation (Reference)
Participants will receive single injection of 180 mcg of PEG-IFN alfa-2a market formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).
Other Name: Pegasys




Primary Outcome Measures :
  1. Maximum Observed Concentration (Cmax) for PEG-IFN alfa-2a [ Time Frame: Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose ]
  2. Area Under the Concentration-Time Curve (AUC) for PEG-IFN alfa-2a From Time Zero to 816 hours (AUC0-816h) [ Time Frame: Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose ]

Secondary Outcome Measures :
  1. Area Under the Concentration-Time Curve for PEG-IFN alfa-2a From Time Zero Extrapolated to Infinity (AUC0-inf) [ Time Frame: Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose ]
  2. Time to Reach Cmax (tmax) for PEG-IFN alfa-2a [ Time Frame: Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose ]
  3. Terminal Half-Life (t1/2) for PEG-IFN alfa-2a [ Time Frame: Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose ]
  4. Percentage of Participants With Adverse Events [ Time Frame: Baseline up to 35 days post last dose of PEG-IFN alfa-2a (maximum up to 17.5 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female and male Chinese participants
  • Body mass index between 19 and 28 kilograms per square meter (kg/m^2), inclusive
  • Participants determined as healthy by their medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory measurements performed at the Screening visit
  • Female participants of childbearing potential: willing to use highly effective methods of contraception throughout the study and for 90 days after the last dosing
  • Male participants: agreement to remain abstinent or use spermicide and barrier method contraception throughout the study and for 90 days after the last dosing
  • Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

  • Any clinically relevant condition or history of cardiovascular, psychiatric, gastrointestinal, respiratory, renal, hepatic, hematological, lymphatic, neurological (including seizure history), musculoskeletal, genitourinary, immunological, metabolic, malignant, or dermatological disorder
  • Participants who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV) or human immunodeficiency virus I and II antibody (anti-HIV I, anti-HIV II) tests at Screening
  • Participants with alanine aminotransferase (ALT) above the upper limit of normal at Screening or on Day -1 of Period 1
  • Any other condition or disease (other than those already stated) which, in the judgment of the Investigator, would place the participant at undue risk, interfere with the absorption, distribution, metabolism, and excretion of PEG-IFN alfa-2a, or interfere with the ability of the participant to complete the study
  • History of drug or alcohol abuse within the last year before screening
  • Treatment with interferon or PEG-IFN alfa-2a within 3 months prior to the first dosing
  • Female participants who are pregnant, currently lactating, or have a positive serum pregnancy test at screening or have a positive urine pregnancy test on Day -1 of Period 1
  • Use of any prescribed or over the counter medication or herbal medicine taken within 14 days prior to the first dosing or within 5 times the elimination half-life of the medication prior to the first dosing (whichever is longer). Exceptions are paracetamol, the contraceptive pill, hormone replacement therapy and commonly used vitamin supplements, which are permitted
  • Regular smoking with consumption of more than 10 cigarettes per day or an equivalent amount of tobacco
  • Participation in an investigational drug or device study within 3 months prior to the first dosing

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): NCT02573025


Locations
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Australia, South Australia
CMAX A division of IDT Australia Limited
Adelaide, South Australia, Australia, 5000
Hong Kong
The University of Hong Kong; Pharmacy Clinical Trials
Hong Kong, Hong Kong
The Chinese University of Hong Kong; Emergency Medicine
Shatin, Hong Kong, 00000
New Zealand
Christchurch Clinical Studies Trust
Christchurch, New Zealand, 8011
Auckland Clinical Studies Limited
Grafton, New Zealand, 1010
Singapore
SingHealth Investigational Medicine Unit; Haematology
Singapore, Singapore, 169608
Changi General Hospital- Parent; Department of Rheumatology
Singapore, Singapore, 529889
Taiwan
China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H
Taichung, Taiwan, 404
Taipei Medical University Hospital; Clinical Research Center
Taipei City, Taiwan, 110
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02573025    
Other Study ID Numbers: YV29573
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Peginterferon alfa-2a
Interferon-alpha
Interferon alpha-2
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents