Healthy Subjects
Conditions
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.
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.
Interventions
DRUGTR-701 FA with PSE
TR-701 FA Oral 200 mg oral with PSE
OTHERTR-701 FA Placebo with PSE
TR-701 FA Placebo Oral 200 mg with PSE
Sponsors
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 13 days | To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo |
Countries
United States
Outcome results
None listed