Clinical trial NCT02573025: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-09
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Maximum Observed Concentration (Cmax) for PEG-IFN alfa-2a
timeFrame: 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
measure: Area Under the Concentration-Time Curve (AUC) for PEG-IFN alfa-2a From Time Zero to 816 hours (AUC0-816h)
timeFrame: 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 outcomes:
measure: Area Under the Concentration-Time Curve for PEG-IFN alfa-2a From Time Zero Extrapolated to Infinity (AUC0-inf)
timeFrame: 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
measure: Time to Reach Cmax (tmax) for PEG-IFN alfa-2a
timeFrame: 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
measure: Terminal Half-Life (t1/2) for PEG-IFN alfa-2a
timeFrame: 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
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to 35 days post last dose of PEG-IFN alfa-2a (maximum up to 17.5 weeks)
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX A division of IDT Australia Limited
state: South Australia
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong; Pharmacy Clinical Trials
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong; Emergency Medicine
city: Christchurch
country: New Zealand
facility: Christchurch Clinical Studies Trust
city: Grafton
country: New Zealand
facility: Auckland Clinical Studies Limited
city: Singapore
country: Singapore
facility: SingHealth Investigational Medicine Unit; Haematology
city: Singapore
country: Singapore
facility: Changi General Hospital- Parent; Department of Rheumatology
city: Taichung
country: Taiwan
facility: China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital; Clinical Research Center
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: