Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA)
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 5/20/2016 |
| Start Date: | September 2009 |
| End Date: | January 2010 |
A Double-Blind, Placebo-Controlled, Single & Multiple Ascending Dose, Safety, Tolerability, & PK Study of an IV Form of TR-701 Free Acid & an Open-Label, Crossover Absolute BA Determination of a TR-701 FA Tablet in Normal Healthy Adults
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
single rising and multiple rising IV doses of TR-701 FA and to determine the absolute
bioavailability of oral TR-701 FA following single oral and IV dose administrations in
healthy adult subjects.
single rising and multiple rising IV doses of TR-701 FA and to determine the absolute
bioavailability of oral TR-701 FA following single oral and IV dose administrations in
healthy adult subjects.
SAD/Part A.
- All subjects in the Pilot Cohort will receive a single infusion of 50 mg TR-701 FA for
injection in 250 cc of saline over 180 minutes.
- Subjects in Cohort 1 will be randomized to receive a single infusion of placebo or 100
mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.
- Subjects in Cohort 2 will be randomized to receive a single infusion of placebo or 200
mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.
- Subjects in Cohort 3 will be randomized to receive a single infusion of placebo or 400
mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.
MAD/Part B
- Subjects in Cohort 4 will be randomized to receive once daily infusions of placebo or
200 mg of TR-701 FA for injection in 250 cc of saline over 60 minutes for 7 days.
- Subjects in Cohort 5 will be randomized to receive once daily infusions of placebo or
300 mg of TR-701 FA for injection in 250 cc of saline over 60 minutes for 7 days.
BA/Part C
- Subjects in Cohort 6 will receive a single 60 minute infusion of 200 mg TR-701 FA for
injection in 250 cc of saline and a singe oral dose of 200 mg TR-701 FA tablet in an
open-label crossover design.
Venous Tolerability/Part D
- Subjects in Cohort 8 will receive once daily 60 minute infusions of 200 mg TR-701 FA for
injection in 250 cc of saline for 3 days and once daily placebo infusions for 3 daysin a
blinded crossover design.
- All subjects in the Pilot Cohort will receive a single infusion of 50 mg TR-701 FA for
injection in 250 cc of saline over 180 minutes.
- Subjects in Cohort 1 will be randomized to receive a single infusion of placebo or 100
mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.
- Subjects in Cohort 2 will be randomized to receive a single infusion of placebo or 200
mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.
- Subjects in Cohort 3 will be randomized to receive a single infusion of placebo or 400
mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.
MAD/Part B
- Subjects in Cohort 4 will be randomized to receive once daily infusions of placebo or
200 mg of TR-701 FA for injection in 250 cc of saline over 60 minutes for 7 days.
- Subjects in Cohort 5 will be randomized to receive once daily infusions of placebo or
300 mg of TR-701 FA for injection in 250 cc of saline over 60 minutes for 7 days.
BA/Part C
- Subjects in Cohort 6 will receive a single 60 minute infusion of 200 mg TR-701 FA for
injection in 250 cc of saline and a singe oral dose of 200 mg TR-701 FA tablet in an
open-label crossover design.
Venous Tolerability/Part D
- Subjects in Cohort 8 will receive once daily 60 minute infusions of 200 mg TR-701 FA for
injection in 250 cc of saline for 3 days and once daily placebo infusions for 3 daysin a
blinded crossover design.
Inclusion Criteria:
- in good health
- body mass index of 20 to 29.9 kg/m2
- female subjects must be post menopausal for at least 1 year, surgically sterile,
abstinent or agree to use an effective method of birth control
Exclusion Criteria:
- history or clinical manifestation of any clinically significant disorder
- history of hypersensitivity to any drug compound
- history of stomach or intestinal surgery or resection
- history of infections of unexplained frequency or severity
- history of alcoholism or drug addiction within 1 year
- use of any tobacco- or nicotine-containing products within 6 months
- use of alcohol-, grapefruit-, caffeine-, or high tyramine-containing foods or
beverages
- use of any other medications
- pregnancy, lactation, or breastfeeding
We found this trial at
1
site
Click here to add this to my saved trials
