Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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17 August 2015 |
Main ID: |
NCT02515695 |
Date of registration:
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24/07/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Phase I BP Interferon (IFN) Beta-001
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Scientific title:
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Bioavailability, Pharmacokinetic and Pharmacodynamic Profile of Interferon Beta-1a (Bioferon®) Administered i.v. and s.c. as Single Doses to Healthy Subjects |
Date of first enrolment:
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May 2005 |
Target sample size:
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12 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02515695 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1
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Contacts
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Name:
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Jérôme Biollaz, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire Vaudois |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy male and female subjects aged between 18 and 45 years
- Weight range between 55 and 95 kg for males, 45 and 80 kg for females, providing body
mass index (BMI) was between 18 and 29 kg/m2
- Absence of significant findings in the medical history and physical examination
- Absence of significant laboratory abnormalities as judged by the investigator.
- 12-lead ECG without significant abnormalities
- Negative urine drug screen
Exclusion Criteria:
- History of major renal, hepatic, immunological, haematological, gastrointestinal,
genitourinary, neurological, or rheumatological disorders
- Active diseases of any type, even if mild, including inflammatory disorders and
infections.
- Pregnant or lactating women or women contemplating becoming pregnant during study.
Female subjects of child-bearing potential who did not practice efficient
contraception during the study. A pregnancy test in blood was performed at screening
and before each period with ß-human chorionic gonadotropin for females of
child-bearing potential. If pregnancy test was positive, the subject had to be
immediately excluded from study and followed until delivery
- History of severe allergy or of asthma at any time.
- History of cardiovascular dysfunction
- Hypertension
- Sick sinus syndrome or known long QT syndrome
- Presence of QTc ? > 440 msec or pronounced sinus bradycardia (<40 bpm/min), even if
elicited by sport
- Dark skin preventing local tolerance assessment or abnormal cutaneous reaction e.g.
urticaria or papular dermographism
- Intense sport activities.
- Any clinically significant laboratory value on screening that were not within normal
range on single repeat
- Positive hepatitis B & C antigen screen
- Positive HIV antibody screen or screen not performed
- Any recent acute illness or sequelae thereof which could expose the subject to a
higher risk or might confound the results of the study
- Treatment in the previous three months with any drug known to have well-defined
potential for toxicity to a major organ
- History of hypersensitivity to any drug if considered as serious
- History of alcohol or drug abuse
- Positive qualitative urine drug test at screening
- Use of any medication in 2 weeks prior to study and throughout study, including
aspirin or other over-the-counter preparation.
- Blood (500 mL) donation or hemorrhage during the previous three months
- Participation in a clinical trial in the previous 3 months
- Smoking
- Consumption of a large quantity of coffee, tea or equivalent
- Present consumption of a large quantity of alcohol or wine or equivalent
- Psychological status which could have had an impact on subject's ability to give
informed consent or behavioral tests
- Any feature of subject's medical history or present condition which, in the
investigator's opinion, could confound the results of the study, complicate its
interpretation, or represent a potential risk for the subject
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis, Relapsing-Remitting
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Intervention(s)
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Drug: Interferon beta-1a
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Primary Outcome(s)
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Composite of interferon beta-1a PD markers
[Time Frame: 0, 6, 12, 24, 48, 72, 96, 120, 168 [hours post-dose]]
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Composite of interferon beta-1a PK parameters
[Time Frame: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 [hours post-dose]]
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Secondary Outcome(s)
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Composite of clinical laboratory tests as a measure of safety and tolerability
[Time Frame: Screening and 0, 24 [hours post-dose]]
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Electrocardiogram (ECG) as a measure of safety and tolerability
[Time Frame: Screening and 0, 8 [hours post-dose]]
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Sickness behavior assessment
[Time Frame: 0, 2, 4, 6, 8, 10, 12 [hours post-dose]]
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Composite of vital signs as a measure of safety and tolerability
[Time Frame: Screening and 0, 1, 2, 4, 6, 8, 10, 12, 24 [hours post-dose]]
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Composite of local reactions as a measure of local tolerance
[Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 24 [hours post-dose] and then daily if needed until Day 5 or longer until resolution in case of local reaction]
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Number of participants with adverse events (AE)/serious adverse event (SAE) as a measure of safety and tolerability
[Time Frame: Up to Day 7]
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Secondary ID(s)
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CE 92/05
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2005DR1151
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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