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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. |
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Register:
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EUCTR |
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Last refreshed on:
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24 July 2012 |
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Main ID: |
EUCTR2008-001714-24-GB |
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Date of registration:
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28/05/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Scientific title:
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A Phase II, Double-Blind Placebo-Controlled Study to Determine the Prophylactic Efficacy of Oral BTA798 in an Experimental Rhinovirus Challenge Model -
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Date of first enrolment:
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18/06/2008 |
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Target sample size:
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240 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001714-24 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
A subject will be considered eligible for inclusion in this clinical trial only if all of the
following criteria apply:
1. Males between the age 18 to 45 years, inclusive;
2. Body Mass Index between 18 and 33 kg/m2 inclusive;
3. Comprehension of the study requirements; availability for the required study
period, ability to attend scheduled study visits, and willingness to participate in
the quarantine challenge phase;
4. Subjects will have given their written informed consent to participate in the study
and to abide by the study restrictions;
5. Good general health status as determined by medical history, physical
examination including vital signs, 12-lead ECG and clinical laboratory tests, and
with no disease that the Investigator regards as clinically relevant;
6. Agreement to use a double-barrier method (condom/spermizide) as a method of
birth control for any sexual contact for 90 days after the end of quarantine phase;
7. Normal lung function tests as defined by a forced expiratory volume in 1 second
(FEV1) greater than 80% of predicted for age, gender, ethnicity and height and a
forced expiratory ratio (FER) (FER= FEV1/FVC) greater than or equal to 80%;
8. Able to tolerate nasal wash procedure;
9. No detectable levels of HRV neutralising antibodies;
10. Negative results in HIV antibody, HBsAg and Hepatitis C antibody tests;
11. Willingness to abstain from alcohol and caffeine-containing food and beverages
for 48 hours prior to dosing and for the duration of the clinical trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Presence of household member or close contact (for an additional two weeks after
the discharge from the isolation facility) who is:
a. less than 3 years of age;
b. any person with any know immunodeficiency;
c. any person receiving immunosuppressant medications;
d. any person undergoing or soon to undergo cancer chemotherapy within 28
days of challenge;
e. any person who has diagnosed emphysema, asthma or COPD, is elderly
residing in a nursing home, or with severe lung disease; or
f. any person who has received a transplant (bone marrow or solid organ).
2. Health care workers (including doctors, nurses, medical students and allied
healthcare professionals) anticipated to have patient contact within two weeks of
the viral challenge. Healthcare workers who volunteer should not work withpatients until 14 days after discharge or until their symptoms are fully resolved (whichever is the longer);
3. History of seasonal hay fever or a seasonal allergic rhinitis (SAR), including the
use of symptomatic only medication and non prescription medication.
4. Chronic use (more than once a week in any two [2] of the four [4] weeks
preceding the first BTA798 dose) of any medication or other product (prescription
or over-the-counter), for symptoms of rhinitis or nasal congestion or any chronic
nasopharyngeal complaint, or chronic use of any intranasal medication for any
indication;
5. Acute use of any medication or other product, prescription or over-the-counter,
for symptoms of rhinitis or nasal congestion within seven (7) days prior to the
first BTA798 dose;
6. Use of any prescription medication during the fourteen days prior to dosing;
7. Subjects who have received any medications known to chronically alter drug
absorption or elimination processes within 30 days of the first dose
administration;
8. Subjects who are current smokers or have been non-smokers for less than 6
months prior to dosing, or have a cumulative smoking history of 10 or more pack
years;
9. Subjects who are unwilling to desist from smoking from the first study visit to the
final follow-up visit, as evidenced by a positive urine cotinine test at first study
visit, and at quarantine entry;
10. Receipt of any investigational HRV vaccine within six (6) months prior to
challenge, or prior participation in a clinical trial of any investigational vaccine or
experimental viral challenge delivered to the respiratory tract within one (1) year
prior to challenge;
11. Presence of any febrile illness or symptoms suggestive of upper respiratory tract
infection between admission for virus challenge and administration of the
challenge inoculum;
12. History of epistaxis;
13. History or clinical evidence of significant respiratory disease (including asthma,
chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF) and/or
recurrent lower respiratory tract infection at any time, or upper respiratory tract
infection within the last month, or lower respiratory tract infection within the last
three months;
14. History or clinical evidence of significant cerebrovascular, cardiovascular,
gastrointestinal, or haematological disease, or myocardial infarction, or a
previous history of any other underlying disease (including immunocompromised
subjects and/or neutropenic subjects) that, in the opinion of the Investigator
would interfere with subject safety or the conduct of the clinical trial;
15. History or clinical evidence of renal disease (including renovascular occlusive
disease), nephrectomy an
Age minimum:
Age maximum:
Gender:
Female: no
Male: yes
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Health Condition(s) or Problem(s) studied
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BTA798 is an investigational drug being developed as a potential agent for treatment and prevention of the common cold.
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Intervention(s)
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Product Name: BTA798
Product Code: BTA798
Pharmaceutical Form: Capsule, hard
Current Sponsor code: BTA798
Other descriptive name: 3-Ethoxy-6-{2-[1-(6-methylpyridazin-3-yl)piperidin-4-yl]ethoxy}-benzo[d]iso-xazole phosphoric acid 1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25, 100, 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: 1) To evaluate the efficacy of BTA798 in preventing HRV infection
2) To evaluate the efficacy of BTA798 in preventing upper respiratory tract illness.
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Secondary Objective: To evaluate the efficacy of BTA798 in reducing the severity of HRV infection,
namely:
- Upper respiratory tract symptom score;
- Mucus production;
- Duration of infection.
• To evaluate the effect of BTA798 on virological endpoints, namely:
- Total Viral Load days 1-5;
- Peak Viral titre;
- Daily viral titre.
• To evaluate the effect of BTA798 on other clinical symptoms and signs;
• To assess safety and tolerability of BTA798;
• To evaluate plasma pharmacokinetics of BTA798 during HRV infection in a
random subset of the study population;
• To assess, at a future point, the potential for emergence of resistance to
BTA798.
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Primary end point(s): The efficacy of BTA798 will be assessed in terms of:
• Incidence of HRV infection as measured by positive quantitative viral culture
from nasal wash.
• Incidence of upper respiratory tract illness (see Section 8 for definition).
Additional efficacy and safety data will be assessed in terms of:
• Group mean viral load as measured by AUC of log10 viral titre versus time
(inoculation to day 5) and quantitative PCR;
• Group mean total symptom score in infected participants;
• Daily group mean viral titre (to day 7);
• Comparison of individual symptoms;
- Self-assessed total upper respiratory tract infection scores;
- Group mean systemic illness scores;
- Group mean physician scores;
- Group mean combined physician and patient-reported scores for upper
respiratory tract infection;
• Mucus weights from nasal discharge;
• Safety;
• Plasma pharmacokinetics of BTA798 during multiple dosing in a subgroup of
subjects;
• Immunological response to inoculation.
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Secondary ID(s)
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BTA798-CL2-001
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Source(s) of Monetary Support
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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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