A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response
2 other identifiers
interventional
18
1 country
1
Brief Summary
This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2012
CompletedFirst Posted
Study publicly available on registry
April 13, 2012
CompletedStudy Start
First participant enrolled
April 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2012
CompletedAugust 21, 2018
August 1, 2018
2 months
April 11, 2012
August 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Systolic Blood Pressure
To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo
13 days
Study Arms (2)
TR-701 FA with PSE
EXPERIMENTALTR-701 FA 200 mg oral with PSE
TR-701 FA Placebo with PSE
PLACEBO COMPARATORTR-701 FA Placebo 200 mg oral with PSE
Interventions
TR-701 FA Oral 200 mg oral with PSE
Eligibility Criteria
You may qualify if:
- Male or female subjects between 18 and 45 years of age, inclusive
- Healthy males and females with no clinically significant abnormalities identified by a detailed medical history
- Body mass index ≥ 19.0 kg/m2 and ≤ 31.0 kg/m2
You may not qualify if:
- Systolic blood pressure \> 130 mmHg or \< 90 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
- Diastolic blood pressure \> 90 mmHg or \< 60 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
- Heart rate \> 90 bpm or \< 50 bpm measured after 10 minutes supine at the Screening Visit and Study Day
- Known allergy or hypersensitivity to PSE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Trius Investigator Site 001
Overland Park, Kansas, 66212, United States
Related Publications (2)
Flanagan S, Minassian SL, Prokocimer P. Pharmacokinetics of Tedizolid and Pseudoephedrine Administered Alone or in Combination in Healthy Volunteers. J Clin Med. 2018 Jun 14;7(6):150. doi: 10.3390/jcm7060150.
PMID: 29899212RESULTFlanagan S, Bartizal K, Minassian SL, Fang E, Prokocimer P. In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions. Antimicrob Agents Chemother. 2013 Jul;57(7):3060-6. doi: 10.1128/AAC.00431-13. Epub 2013 Apr 22.
PMID: 23612197DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Philippe G Prokocimer, MD
Trius Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2012
First Posted
April 13, 2012
Study Start
April 23, 2012
Primary Completion
June 15, 2012
Study Completion
June 15, 2012
Last Updated
August 21, 2018
Record last verified: 2018-08