Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 9/1/2017 |
| Start Date: | December 8, 2010 |
| End Date: | January 3, 2011 |
Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg TR-701 Free Acid in Healthy Volunteers
The primary purpose of this study is to determine the steady-state plasma pharmacokinetics
(PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar
macrophages (AM) of healthy volunteers.
(PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar
macrophages (AM) of healthy volunteers.
No applicable.
Inclusion Criteria:
- Healthy males and females, between 18 and 55 years of age, inclusive
- Females must be nonpregnant, nonlactating, and either postmenopausal or surgically
sterile or practicing an effective method of birth control
- Males must be surgically sterile, abstinent, or practicing an effective method of
birth control
- BMI between 20 and 34.9 kg/m2, inclusive
Exclusion Criteria:
- Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes
- Physician-diagnosed migraine headaches within 3 years
- Previous enrollment in a TR-701 or TR-701 FA trial
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