---
title: A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response
nct_id: NCT01577459
overall_status: COMPLETED
phase: PHASE1
sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
study_type: INTERVENTIONAL
primary_condition: Healthy Subjects
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01577459.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01577459"
ct_last_update_post_date: 2018-08-21
last_seen_at: "2026-05-12T06:58:11.813Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response

**Official Title:** A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA

**NCT ID:** [NCT01577459](https://clinicaltrials.gov/study/NCT01577459)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 18
- **Lead Sponsor:** Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- **Conditions:** Healthy Subjects
- **Start Date:** 2012-04-23
- **Completion Date:** 2012-06-15
- **CT.gov Last Update:** 2018-08-21

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** ALL
- **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
```

## Arms

- **TR-701 FA with PSE** (EXPERIMENTAL) — TR-701 FA 200 mg oral with PSE
- **TR-701 FA Placebo with PSE** (PLACEBO_COMPARATOR) — TR-701 FA Placebo 200 mg oral with PSE

## Interventions

- **TR-701 FA with PSE** (DRUG) — TR-701 FA Oral 200 mg oral with PSE
- **TR-701 FA Placebo with PSE** (OTHER) — TR-701 FA Placebo Oral 200 mg with PSE

## Primary Outcomes

- **Systolic Blood Pressure** _(time frame: 13 days)_ — To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo

## Locations (1)

- Trius Investigator Site 001, Overland Park, Kansas, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.trius investigator site 001|overland park|kansas|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01577459*  
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