Healthy
Conditions
Keywords
Healthy Subjects
Brief summary
The purpose of this study is to evaluate the safety and tolerability of single doses of BLI-489 administered intravenously in healthy Japanese male subjects, and how the drug is absorbed and eliminated.
Interventions
DRUGBLI-489
DRUGPlacebo
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men, aged 20 to 50 years of age inclusive at screening. 2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg. 3. Healthy as determined by the investigator on the basis of the screening evaluations. 4. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.
Exclusion criteria
1. Presence of history of any disorder that may prevent the successful completion of the study. 2. History of drug abuse within 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety as measured by the number of adverse events and serious adverse events. Tolerability will be assessed based upon the occurrence of dose limiting toxicities. | 15 days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics as evaluated by drug concentrations in the blood and urine. | 4 days |
Countries
Japan
Outcome results
None listed