Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: Placebo; Drug: Moxifloxacin; Drug: BMS-708163

Study type: Interventional

Funder types: Industry

Identifiers

NCT00979316

CN156-020

Details and patient eligibility

About

The purpose of this study is to determine the effect of BMS-708163 on the QTc interval (QT interval corrected for heart rate).

Enrollment: 62 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) of 18 to 32 kg/m², inclusive.
• Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55
• Healthy subjects

Exclusion criteria

• History of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope
• Sexually active fertile men not using effective birth control (double barrier) if their partners are WOCBP
• Women who are pregnant or breastfeeding
• History of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents
• History of hypokalemia, history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
• Any clinically significant ECG abnormality
• History of seizure disorders
• History of drowning survival

Trial design

62 participants in 4 patient groups, including a placebo group

BMS-708163 (800 mg)

Experimental group

Treatment:

Drug: BMS-708163

Drug: BMS-708163

BMS-708163 (200 mg)

Experimental group

Treatment:

Drug: BMS-708163

Drug: BMS-708163

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Moxifloxacin

Active Comparator group

Treatment:

Drug: Moxifloxacin