A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the concentration of 31001074 in blood samples from healthy volunteers who have been administered 31001074 and paroxetine.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine

Criteria

Inclusion Criteria:

• Have a body mass index (BMI) (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg

• Have a blood pressure after the healthy volunteer is supine [ie, lying down face up] for 5 minutes between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at screening and at admission to the study center on Day -1

• If a woman, must be of nonchildbearing potential, i.e., postmenopausal (no spontaneous menses for at least 2 years) or surgically sterile

• Be a nonsmoker

Exclusion Criteria:

• Have a history of or a current medical illness that the investigator (study physician) considers to be clinically significant, a history of chronic uveitis (inflammation of the eye persisting for a long time) or any any intraocular surgery (except for cataract extraction, laser in situ keratomileusis [LASIK], or photorefractive keratectomy [PRK] procedures [ie, procedures used to reshape the cornea of the eye])

• Have clinically significant abnormal laboratory values, abnormal ECG, or a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies

• If a woman, be pregnant, lactating or completed last term pregnancy within 6 months before admission to study center on Day -1

• Have known allergy to heparin (agent used to prevent clotting of the blood) or history of heparin induced thrombocytopenia (low blood platelet count as a result of the medication heparin)

• Have intermediate or low activity of CYP2D6 as determined by genetic testing