A Pharmacokinetic and Drug Interaction Study of JNJ-26489112 in Healthy Volunteers

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of 26489112 on the pharmacokinetics (blood levels) of a combination of 3 drugs administered to healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Omeprazole; Tolbutamide

Criteria

Inclusion Criteria:

• If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study and must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening

• If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy at least 6 months before study entry, double barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug

• Body mass index (BMI

• weight [kg]/height [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg

• Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic and results from a 12-lead electrocardiogram (ECG) that are consistent with normal cardiac conduction and function

• Nonsmoker for at least 6 months

Exclusion Criteria:

• History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease including current suicidal ideation or behavior, infection, known history of G6PD deficiency, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

• Known clinically significant ophthalmologic examination results or known ocular deficits, including retinal disorders

• History of clinically significant allergies, known allergy to the study drug or any of the excipients of the formulation, or known allergy to heparin or history of heparin-induced thrombocytopenia