CS-8958 Single Inhaled Dose in Elderly
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.
Timeline
- Start
- 2008-04
- Primary completion
- 2009-10
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Laninamivir Octanoate | Small molecule | 5 mg | Inhaled |
| Subject | Laninamivir Octanoate | Small molecule | 10 mg | Inhaled |
| Subject | Laninamivir Octanoate | Small molecule | 20 mg | Inhaled |
| Subject | Laninamivir Octanoate | Small molecule | 40 mg | Inhaled |