A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response
Information source: Trius Therapeutics LLC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Subjects
Intervention: TR-701 FA with PSE (Drug); TR-701 FA Placebo with PSE (Other)
Phase: Phase 1
Status: Completed
Sponsored by: Trius Therapeutics LLC Official(s) and/or principal investigator(s):
Philippe G Prokocimer, MD, Study Chair, Affiliation: Trius Therapeutics
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.
Clinical Details
Official title: A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Systolic Blood Pressure
Detailed description:
Eligible subjects will be randomized to 1 of 2 possible treatment sequences (N=9 per
sequence) on Study Day 1. Subjects will receive oral 200 mg TR 701 FA or Placebo for TR 701
FA once daily for 5 days during each treatment period, with a 2 day washout between periods
(72 hours between doses). On Study Day 5 of each treatment period, subjects will also
receive oral 60 mg PSE.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Trius Investigator Site 001, Overland Park, Kansas 66212, United States
Additional Information
Starting date: April 2012
Last updated: June 6, 2012
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