- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00983255
Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA) (IV/SAD/MAD)
May 18, 2016 updated by: Trius Therapeutics LLC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53704
- Covance Clinical Research Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SAD/ Part A
Single IV infusions of placebo or TR-701 FA given at 50, 100, 200, and 400 mg.
|
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
Other Names:
|
Experimental: MAD / Part B
Multiple IV infusion of placebo or TR-701 FA given daily for 7 days at 200 and 400 mg.
|
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
Other Names:
|
Experimental: Bioavailability / Part C
TR-701 FA tablet given once orally as a 200 mg tablet or TR-701 FA for injection given once as a 200 mg IV infusion.
|
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
Other Names:
TR-701 FA will be given once orally as a 200 mg tablet in Part C.
Other Names:
|
Experimental: Venous Tolerability/ Part D
IV infusions of placebo and 200 mg TR-701 FA given daily for 3 days,
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety Assessments
Time Frame: 10 days
|
10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the pharmacokinetics of TR-701 and its microbiologically active moiety TR-700 after single and multiple IV doses of TR-701 FA
Time Frame: 10 days
|
10 days
|
To determine the absolute bioavailability of oral TR-701 FA following single oral and IV dose administrations in healthy adult subjects
Time Frame: 4 days
|
4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nicholas Siebers, MD, Covance Clinical Research Unit, Madison, WI, USA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
September 22, 2009
First Submitted That Met QC Criteria
September 23, 2009
First Posted (Estimate)
September 24, 2009
Study Record Updates
Last Update Posted (Estimate)
May 19, 2016
Last Update Submitted That Met QC Criteria
May 18, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1986-008
- TR701-107 (Other Identifier: TriusRX Unique ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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