Status:
COMPLETED
A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Detailed Description
This is an open-label (both volunteer and study physician will know the identity of study treatment) pharmacokinetic study to determine the effects, if any that multiple 20-mg doses of paroxetine have...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01159821
Start Date
August 1 2010
End Date
October 1 2010
Last Update
April 8 2014
Active Locations (1)
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1
Overland Park, Kansas, United States