A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo

NCT00158093 | Completed Phase 1

• 1 other identifier: NEB122
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. The purpose of this study is to explore the potential of nebivolol to cause a certain type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• The primary study endpoint was the change in the average QTc intervals from Day 0 to 2 hours after dosing on Day 7.

Secondary Outcomes (1)

• The secondary endpoints were the change in average QTc intervals from Day 0 to all other evaluation times and the change in other ECG intervals (PR, RR, QRS, QT) and HR from Day 0 to all other evaluation times.

Interventions

Nebivolol DRUG

Atenolol DRUG

Moxifloxacin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and nonpregnant, nonlactating women were 18 years or older.
• Women declaring postmenopausal or surgical sterility.
• Women of childbearing potential who had a negative serum HCG within 2 weeks of dosing.
• Male subjects weighed at least 60 kg (132 lb), and female subjects weighed at least 48 kg (106 lb). All volunteers weighed within 15% of their ideal body weight (IBW).

You may not qualify if:

• Institutionalized
• Reported or was known to have done the following:
• Used any tobacco product.
• Ingested any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to the initial dose of study medication
• Consumed grapefruit or grapefruit containing products within 7 days prior to the initial dose of study medication.
• Ingested any vitamins or herbal products within the 48 hours prior to the initial dose of study medication.
• Recently changed dietary or exercise habits significantly
• Used any medication (including over-the-counter \[OTC\]) within the 14 days prior to the initial dose of study medication.
• Used any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
• Received an investigational drug within 30 days prior to the initial dose of study medication.
• History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
• History of drug and/or alcohol abuse within 1 year prior to the study.
• Acute illness at the time of either the pre study medical evaluation or dosing.
• Any laboratory results deemed clinically significant by the physician.
• Abnormal and clinically relevant ECG tracing.

Sponsors & Collaborators

• Mylan Bertek Pharmaceuticals: lead

Study Sites (1)

SFBC International, Inc.

Miami, Florida, 33181, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol; Atenolol; Moxifloxacin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenoxypropanolamines; Propanolamines; Propanols; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Lawrence A Galitz, MD

  SFBC International

  PRINCIPAL INVESTIGATOR

• Will A Sullivan, BS

  Mylan Bertek Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: June 1, 2003
• Study Completion: July 1, 2003
• Last Updated: September 12, 2005

Record last verified: 2005-09

Locations

US (1)