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CS-8958 Single Inhaled Dose in Elderly

NCT00657111 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-09-17

No results posted yet for this study

Summary

The purpose of this study is to test the safety and tolerability of an investigational inhaled flu medication, CS-8958. Study participants will include 38 elderly males and females, age 65 and older. Participants will be divided into 1 of 4 possible treatment groups (Groups A, B, C and D) to receive the study drug or placebo (substance containing no medication). Group A will receive 5 mg CS-8958, Group B will receive 10 mg CS-8958, Group C will receive 20 mg CS-8958 and Group D will receive 40mg CS-8958. Safety information will be reviewed prior to administering a higher dose of treatment. Study procedures will include blood and urine samples, ECGs (measure of heart activity), and a 7 day clinic stay. Participants will be involved in study related procedures for up to 6 weeks.

Conditions

Interventions

DRUG

CS-8958 formulated as dry powder

CS-8958, formulated as a dry-powder and will be administered from capsules containing 5 mg CS-8958 and lactose to 25 mg (placebo) inserted into a FlowCaps inhaler device.

OTHER

Placebo

placebo capsules containing 25 mg lactose

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Biota Scientific Management Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Douglas ET Lee, MBChB MRCP DGM · Covance CRU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00657111 on ClinicalTrials.gov