Safety, Tolerability and Pharmacokinetic Study of Multiple Doses of CS-8958

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Biota Scientific Management Pty Ltd
ClinicalTrials.gov Identifier:
NCT00995826
First received: October 11, 2009
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to test the safety and tolerability of an investigational multi-dose inhaled flu medication, CS-8958. Study participants will include 16 males and females, aged 18-55 years of age, inclusive. Participants will be divided into two treatment groups (Groups A and B) with each group consisting of 8 subjects. Participants will be involved in study related procedures for a maximum of 14 weeks from initial screen to the follow up visit. 6 subjects in Group A will be administered 40 mg of CS-8958 drug and two subjects will receive placebo (substance containing no medication), once a week for six weeks. In Group B six subjects will be administered 40 mg of CS-8958 drug and two subjects will receive placebo, twice a week for six weeks. Study procedures will include blood and urine samples, ECGs (measure of heart activity), blood pressure, pulse rate and functional oxygen saturation of arterial hemoglobin. Also continuous cardiac telemetry will be performed as well as physical examinations and spirometry assessments.


Condition Intervention Phase
Influenza
Drug: CS-8958
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CS-8958 - A Phase I, Double-blind, Placebo-controlled, Ascending, Multiple Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects.

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

Primary Outcome Measures:
  • Safety and tolerability will be assessed via occurrences of treatment-emergent adverse events, changes in vital signs including BP, PR, SpO2, temperature, ECG, spirometry, physical examinations, and laboratory parameters [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: April 2009
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Other: Placebo
Inhaled placebo
Experimental: CS-8958 DPI Drug: CS-8958
Inhaled CS-8958
Other Name: Laninamivir

Detailed Description:

Influenza is an acute febrile illness caused by influenza A and B virus affecting all age groups.Influenza occurs annually and each year it is estimated that influenza epidemics cause 36,000 deaths and 114,000 hospitalizations in the US alone. Control of human influenza virus infections continues to be a major public health goal.Influenza infects the respiratory tract with a rapid onset of symptoms typically characterized by fever, chills, myalgia, headache, malaise, sore throat and cough. Influenza infections are generally self-limiting; however significant morbidity and mortality can occur, predominantly in high risk groups such as the elderly and those suffering from chronic conditions. It is the objective of this clinical trial to investigate safety and tolerability of multiple doses of CS-8958 administered via inhalation in healthy adult subjects. The pharmacokinetics required for this dosing regimen is only achievable by inhalation delivery. Study participants will include 16 males and females, aged 18-55 years of age, inclusive. The primary objective is to evaluate the safety and tolerability of 40mg CS-8958 once or twice a week (on consecutive days) for 6 weeks in healthy adult subjects after multiple doses administered via inhalation. The secondary objective is to assess the systemic exposure of CS-8958 and its active metabolite R-125489 after single and multiple doses of CS-8958 in healthy adult subjects.

Participants will be divided into two treatment groups (Groups A and B) with each group consisting of 8 subjects. Participants will be involved in study related procedures for a maximum of 14 weeks from initial screen to the follow up visit. 6 subjects in Group A will be administered 40 mg of CS-8958 drug and two subjects will receive placebo (substance containing no medication, once a week for six weeks. In Group B six subjects will be administered 40 mg of CS-8958 drug and two subjects will receive placebo, twice a week for six weeks.

Adverse events will be recorded at every visit. Vital signs including blood pressure, pulse rate and functional oxygen saturation of arterial hemoglobin will be measured on admission, pre-dose and at multiple time points post each dose. ECGs will be performed on admission, pre-dose and at multiple time points post each dose.Continuous cardiac telemetry will be performed for 24 hours post first dose each week for cohort A and 60 hours post first dose each week for cohort B. Spirometry assessments including forced vital capacity, forced expiratory volume in 1 second, forced expiratory volume percentage in 1 second, forced expiratory flow rate, and peak expiratory flow rate will be performed on admission, pre-dose and at multiple time points post dose. Physical examinations will be performed on Day -1 and at the final visit (and as needed if subject develops symptomatology). Blood samples for hematology and biochemistry assessments will be taken on admission, and 24 hours post dose each week. Urine samples for urinalysis tests will be collected on admission, and 24 hours post dose each week. Blood samples for pharmacokinetic testing will be taken pre-dose and at multiple time points post each dose.

The Safety Monitoring Committee (SMC) will review the safety, tolerability and pharmacokinetic data from Cohort A prior to beginning Cohort B.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and Female subjects aged 18 to 55 years, inclusive

Exclusion Criteria:

  • Pregnant or lactating female subjects.
  • Out of range findings in vital signs, physical examination, or lab tests.
  • Intake of any investigational drug within the 4 months prior to Day 0.
  • Positive urine drug screen or alcohol breath test.
  • Significant disease, event, or condition which may impact on subject safety or study compliance.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00995826

Locations
United Kingdom
Covance Clinical Research Unit Limited
Leeds, United Kingdom
Sponsors and Collaborators
Biota Scientific Management Pty Ltd
Investigators
Principal Investigator: Jane Ryan, PhD Biota Scientific Management
  More Information

No publications provided

Responsible Party: Biota Scientific Management Pty Ltd
ClinicalTrials.gov Identifier: NCT00995826     History of Changes
Other Study ID Numbers: 08-0002, 1UC1AI062373-01, 08-0002, 2008-000911-14
Study First Received: October 11, 2009
Last Updated: October 20, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on October 23, 2014