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A Study to Define the ECG Effects of Tizanidine Compared to Placebo and the Positive Control, Moxifloxacin, in Healthy Men and Women Using a Blinded ECG Evaluator: A Thorough ECG Trial

Information source: Acorda Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spasticity

Intervention: Tizanidine (Drug); Placebo (Drug); Moxifloxacin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Acorda Therapeutics

Official(s) and/or principal investigator(s):
Mathews Adera, MD, Study Director, Affiliation: Acorda Therapeutics

Summary

This is a single-center, partial-blind, randomized, placebo-controlled, parallel design study with a nested crossover comparison to define the ECG effects of tizanidine compared to placebo and the positive control, moxifloxacin, in healthy men and women. The study will be conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the protocol.

Clinical Details

Official title: A Partial-Blind, Randomized, Parallel Design Study With a Nested Crossover Comparison to Define the ECG Effects of Tizanidine Compared to Placebo and the Positive Control, Moxifloxacin, in Healthy Men and Women Using a Blinded ECG Evaluator: A Thorough ECG Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The Primary Endpoint Will be the Baseline-adjusted, Placebo-corrected Effect on QTc (ΔΔQTc) on Day 14.

Secondary outcome:

The Baseline-adjusted, Placebo-corrected (ΔΔQTc) on QTc Method Not Selected as Primary Endpoint.

Assessing the Relationship Between Changes in the QTc Interval and Plasma Levels of Tizanidine Using Concentration-effect Modeling

Maximum Plasma Concentration (Cmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.

Time to Reach Maximum Plasma Concentration (Tmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.

Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCt) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Women of childbearing potential should have a negative urine pregnancy test prior to

Screening and Day - 2 of the trial

- All subjects of childbearing potential must practice a highly effective method of

birth control excluding oral contraceptives for the duration of the trial and up to 3 months after the last dose of investigational product. Oral contraceptives are not allowed, based on the precaution listed in the Zanaflex package insert.

- Have a body mass index (BMI) ranging between 19 and 30 kg/m2

- Comprehend and be able to provide written informed consent

- Be willing and able to comply with all trial requirements

Exclusion Criteria:

- Female who is either pregnant, breastfeeding or planning to become pregnant

- History of hypersensitivity or allergic reaction to tizanidine or moxifloxacin or any

of the tablet components

- Any condition possibly affecting drug absorption, metabolism or excretion including

previous surgery for removal of parts of stomach, bowel, liver, gall bladder, or pancreas

- History of Long QT Syndrome or a first-generation relative with this condition

- Evidence or history of clinically significant allergies except for untreated,

asymptomatic, seasonal allergies at time of dosing, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, or neurological disease. Determination of clinical significance is to be made at the Investigator's discretion

- History or presence of any malignant or benign neoplasm considered by the

investigator to be clinically significant

- History of drug or alcohol abuse or dependence within the last year

- Have an active infectious disease

Locations and Contacts

Covance- Dallas, Dallas, Texas 75247, United States
Additional Information

Starting date: April 2013
Last updated: May 12, 2015

Page last updated: August 23, 2015

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