Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously

Inclusion

• Men or women of non childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
• Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg.
• Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital sign measurements, and 12-lead electrocardiogram (ECG).
• Serum creatinine level must be less than 1.30 mg/dL. (Normal range: 0.44 to 1.24 mg/dL.)
• Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion

• Presence or history of any disorder that may prevent the successful completion of the study.
• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the test article.
• Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
• Any history of clinically important cardiac arrhythmias.
• Familial history of long QT syndrome or unexpected cardiac death.
• History of drug abuse within 1 year before study day 1.
• History of alcoholism within 1 year before study day 1.