---
title: A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects
nct_id: NCT01461460
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 Volunteer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01461460.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01461460"
ct_last_update_post_date: 2018-12-05
last_seen_at: "2026-05-12T06:56:08.214Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects

**Official Title:** A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram

**NCT ID:** [NCT01461460](https://clinicaltrials.gov/study/NCT01461460)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 48
- **Lead Sponsor:** Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- **Conditions:** Healthy Volunteer
- **Start Date:** 2011-11-28
- **Completion Date:** 2011-12-23
- **CT.gov Last Update:** 2018-12-05

## Brief Summary

The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.

## Detailed Description

To assess the effects of a single therapeutic (200 mg) and supratherapeutic of oral TR-701 free acid (FA) versus placebo on QT interval corrected for heart rate using Fridericia's formula (QTcF) in healthy subjects.

## 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.
* Body mass index ≥18.0 kg/m2 and ≤30.0 kg/m2

Exclusion Criteria:

* Sustained supine systolic blood pressure \>140 or \<100 mmHg or a diastolic blood pressure \>90 or \<60 mmHg at the Screening and Day 1 Visit.
* Abnormal ECG at Screening or Day -1 Visits indicating a second or third-degree atrioventricular block, or QRS \>110 msec, QTcF \>450 msec for males and \>470 msec for females, PR interval \>200 msec, or any rhythm other than sinus rhythm which is interpreted by the Investigator as clinically significant - History of unexplained infections or current signs of infection
* History of risk factors for Torsades de Pointes, including unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, hypomagnesemia, or family history of Long QT Syndrome or Brugada Syndrome
```

## Arms

- **Moxifloxacin 400 mg** (ACTIVE_COMPARATOR)
- **TR-701 FA 1200 mg** (EXPERIMENTAL)
- **TR-701 FA 200 mg plus Placebo** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **TR-701 FA 1200 mg** (DRUG) — 6 tablet of T-701 FA
- **Moxifloxacin 400 mg** (DRUG) — 1 tablet 400 mg Moxifloxacin
- **TR-701 FA 200 mg plus Placebo** (DRUG) — 1 tablet of TR-701 FA with 5 tablet placebo
- **Placebo** (DRUG) — 6 placebo tablets

## Primary Outcomes

- **QTcF Change from Baseline** _(time frame: 24 Hours)_ — Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).

## Locations (1)

- Trius Investigator, Dallas, Texas, 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|dallas|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01461460.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01461460*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*