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
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