Safety Study of Oral BTA9881 to Treat RSV Infection

This study has been completed.
Sponsor:
Information provided by:
Biota Scientific Management Pty Ltd
ClinicalTrials.gov Identifier:
NCT00504907
First received: July 18, 2007
Last updated: October 11, 2009
Last verified: October 2009
  Purpose

This is a placebo-controlled, double-blind, randomised, single dose escalation Phase I clinical trial to determine the safety and tolerability of BTA9881 administered orally to healthy subjects


Condition Intervention Phase
Respiratory Syncytial Virus Infections
Drug: BTA9881
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Single-Centre, Double-Blind, Placebo-Controlled, Escalating Single Oral Dose, Safety and Tolerability Clinical Trial With BTA9881 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Biota Scientific Management Pty Ltd:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of ascending single oral doses of BTA9881 in healthy adult subjects. [ Time Frame: Two weeks ]

Secondary Outcome Measures:
  • To assess the pharmacokinetics and dose proportionality of BTA9881 after a single oral dose in healthy adult subjects [ Time Frame: Two weeks ]

Estimated Enrollment: 81
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BTA9881
    Single oral escalating doses
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and female subjects >=18 and <=45 years of age.
  2. Individuals who have freely given Informed Consent in writing.
  3. Male subjects should use appropriate contraception (e.g. condoms) during the time interval between dosing until three months after dosing. Female subjects must be surgically sterile or post-menopausal (defined as at least two years post cessation of menses and/or follicle-stimulating hormone (FSH) >18 mIU/mL and serum oestradiol <110 pmol/L), or must agree to use two forms of the following contraception: oral contraceptives, or other forms of hormonal birth control including hormonal vaginal rings or transdermal patches, intra-uterine devices, condoms, and spermicide during the time interval between dosing until three months after dosing. Female subjects must also be non-lactating and have a negative serum pregnancy test at screening and at baseline.
  4. Able to perform nasal wash procedure.
  5. Normotensive (systolic BP ≤ 140 mm Hg and diastolic BP ≤ 90 mm Hg).
  6. No abnormal finding of clinical relevance at the screening examination that the Investigator considers might interfere with the objectives of this clinical trial.
  7. No clinically relevant abnormality in the ECG; QTc <430 ms (males) or <450 ms (females).
  8. Healthy based on medical history, physical examination, 12-lead ECG and clinical laboratory tests, and with no disease that the Investigator regards as clinically relevant.
  9. Negative results in Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface antigen (HBsAg) and Hepatitis C antibody tests.
  10. 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.

Exclusion Criteria:

  1. Use of any prescription medication (other than allowable oral contraceptives and implanted hormonal contraceptives) during the 14 days prior to dosing.
  2. Use of any non-prescription ('over the counter') product, including herbal products, diet aids, hormone supplements, etc., within 14 days prior to dosing.
  3. Intake of any investigational drug within 3 months prior to dosing.
  4. History or clinical evidence of significant cardiovascular disease (including risk factors for cardiac arrhythmias) or a previous history of any cardiovascular condition that, in the opinion of the investigator, would interfere with the conduct of the trial.
  5. History or clinical evidence of significant cerebrovascular, cardiovascular, gastrointestinal, or haematological disease, or myocardial infarction, or a previous history of any other serious underlying disease (including immunocompromised subjects and/or neutropenic subjects) that, in the opinion of the investigator would interfere with the conduct of the clinical trial.
  6. History or clinical evidence of significant respiratory disease (including asthma, chronic obstructive pulmonary disease, cystic fibrosis and/or recurrent lower respiratory tract infection), or upper respiratory tract infection within the last month or lower respiratory tract infection within the last three months.
  7. History or clinical evidence of renal disease (including renovascular occlusive disease), nephrectomy and/or renal transplant, and/or previous clinically significant laboratory abnormalities of renal function parameters. All subjects with serum creatinine or proteinuria outside the normal laboratory reference range at screening and baseline that are regarded by the Investigator as clinically significant.
  8. History or clinical evidence of hepatic disease and/or previous clinically significant laboratory abnormalities of liver function parameters. All subjects with bilirubin, gamma glutamyl transferase (GGT), alanine transaminase (ALT), and aspartate transaminase (AST) outside the normal laboratory reference range at screening and baseline, that are regarded by the Investigator as clinically significant. Subjects known to have experienced elevated liver enzyme values in previous clinical studies will also be excluded.
  9. History or clinical evidence of adrenal disease (including Cushing's Syndrome or Addison's disease) or thyroid disease (including hyper or hypothyroidism), and/or previous clinically significant laboratory abnormalities of adrenal or thyroid function parameters. All subjects with thyroid function (TSH, FT4, FT3) outside the normal laboratory reference range at baseline and regarded by the Investigator as clinically significant.
  10. Psychiatric or emotional problems that would invalidate the giving of Informed Consent or limit the ability of the subject to comply with clinical trial requirements.
  11. Body Mass Index (BMI) ≤18.5 kg/m2 or >=30.0 kg/m2.
  12. History of alcohol and/or drug abuse within 1 year prior to screening (verified by drug screening).
  13. Receipt of blood or blood products, or loss of 450 mL or more of blood, during the last three months prior to dosing.
  14. Unwillingness or inability to provide Informed Consent or to participate satisfactorily for the entire clinical trial period.
  15. Subjects who smoke or have been non-smokers for less than 3 months prior to dosing.
  16. Subjects who were previously enrolled in this clinical trial.
  17. Poor veins, or fear of venipuncture or sight of blood, or known allergy or hypersensitivity to lidocaine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504907

Locations
Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Biota Scientific Management Pty Ltd
Investigators
Principal Investigator: Peter Hodsman, MD Nucleus Network
  More Information

No publications provided

Responsible Party: John Lambert, Principal Director Product Development Operations, Biota Scientific Management
ClinicalTrials.gov Identifier: NCT00504907     History of Changes
Other Study ID Numbers: BTA9881-01
Study First Received: July 18, 2007
Last Updated: October 11, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Biota Scientific Management Pty Ltd:
RSV

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on July 26, 2014