A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01159821
- Run by
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- People needed
- 14
- Starts
- 2010-08-01
- Expected to finish
- 2010-10-01
- Last updated by the study team
- 2014-04-08
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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