Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults (SAD/MAD)
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|ClinicalTrials.gov Identifier: NCT00671814|
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : August 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects||Drug: TR-701 Drug: linezolid Drug: placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Double-Blind, Placebo and Active Controlled, Single and Multiple Rising Dose, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults|
|Actual Study Start Date :||January 6, 2008|
|Actual Primary Completion Date :||June 6, 2008|
|Actual Study Completion Date :||June 6, 2008|
Single oral dose of TR-701 given once at 200mg, 400mg, 600mg, 800mg, and 1200mg. Multiple oral doses of TR-701 given once daily for 21 days at 200mg, 300mg and 400mg.
TR-701 will be given as single oral doses in Cohorts 1-5 and as once daily oral doses for 21 days in cohorts 6-8.
Placebo Comparator: 2
Single oral dose of placebo given in cohorts 1-5. Multiple oral doses of placebo given once daily for 21 days in cohorts 6-8 and twice daily for 21 days in cohort 10.
Placebo will be given once for cohorts 1-5, once daily for 21 days for cohorts 6-8, and twice daily for 21 days for cohort 10.
Active Comparator: 3
Oral doses of 600mg linezolid given twice daily for 21 days.
Linezolid will be given at 600 mg twice daily for 21 days in cohort 10.
- Adverse Event reporting [ Time Frame: 21 days ]
- The PK rate and extent of urinary excretion of TR-701 and its microbiologically active moiety, TR-700 [ Time Frame: 21 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671814
|United States, Wisconsin|
|Covance Clinical Research Unit|
|Madison, Wisconsin, United States, 53704|
|Principal Investigator:||John Bohn, MD||Covance Clinical Research Unit|