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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00983255
Other study ID # 1986-008
Secondary ID TR701-107
Status Completed
Phase Phase 1
First received September 22, 2009
Last updated May 18, 2016
Start date September 2009
Est. completion date January 2010

Study information

Verified date May 2016
Source Trius Therapeutics LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
TR-701 FA for injection, 200 mg/vial
TR-701 FA for injection will be given as a single infusion at doses of 50 mg, 100 mg, 200 mg, and 400 mg in SAD/Part A (Pilot and Cohorts 1 to 3). TR-701 FA for injection will be given as once daily infusions at doses of 200 mg and 400 mg for 7 days in MAD/Part B (Cohorts 4 & 5). TR-701 FA for injection will be given once as a 200 mg IV infusion in BA/Part C (Cohort 6). TR-701 FA 200 mg will be given daily for 3 days in Venous Tolerability/Part D
TR-701 FA tablets
TR-701 FA will be given once orally as a 200 mg tablet in Part C.

Locations

Country Name City State
United States Covance Clinical Research Unit Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Trius Therapeutics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Assessments 10 days Yes
Secondary To evaluate the pharmacokinetics of TR-701 and its microbiologically active moiety TR-700 after single and multiple IV doses of TR-701 FA 10 days No
Secondary To determine the absolute bioavailability of oral TR-701 FA following single oral and IV dose administrations in healthy adult subjects 4 days No
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