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

NCT00995826 | Completed Phase 1 DMC

• 3 other identifiers: 08-00021UC1AI062373-012008-000911-14
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• 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

  Duration of study

Study Arms (2)

placebo

PLACEBO COMPARATOR

Other: Placebo

CS-8958 DPI

EXPERIMENTAL

Drug: CS-8958

Interventions

CS-8958 DRUG

Inhaled CS-8958

Also known as: Laninamivir

CS-8958 DPI

Placebo OTHER

Inhaled placebo

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biota Scientific Management Pty Ltd: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Covance Clinical Research Unit Limited

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

CS 8958; laninamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Jane Ryan, PhD

  Biota Scientific Management Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2009
• First Posted: October 15, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

GB (1)