Track topics on Twitter Track topics that are important to you
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.
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 on the concentration of a single dose of study drug (referred to as 31001074) in the bloodstream after paroxetine and 31001074 are administered orally (by mouth) to healthy adult volunteers. Paroxetine is an approved drug used to treat patients with psychiatric disorders and 31001074 is a drug that is currently under development for potential uses in the treatment of patients with nervous system disorders. Approximately 14 healthy volunteers will participate in the study for approximately 45 days (includes a screening period of up to 29 days to determine eligibility and a 16 day treatment period). Volunteers will be required to stay overnight at the study center during the 16-day treatment period. During the 16-day treatment period, volunteers will receive 2 doses of 31001074 and 12 doses of paroxetine. At Screening, a blood sample will be collected from all volunteers for pharmacogenomic analysis (ie, genetic testing) to identify volunteers genetically-determined to have high activity of an enzyme (CYP2D6) that is involved in the processing of 31001074 by the body. Additional blood samples will be obtained from volunteers at protocol-specified time points during the study to determine the concentration of 31001074 and paroxetine in plasma (the colorless portion of blood). Safety will be evaluated during the study by monitoring adverse events (side effects) reported and findings from clinical laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations performed. In addition, volunteers will be instructed to report the occurrence of adverse events that are considered by the study physician to be serious (as defined by the protocol) for up to 30 days after the administration of the last dose of study drug. A single dose of 31001074 will be administered on Day 1 and Day 13 (total 2 doses). Paroxetine will be administered once daily from Days 4 through 15 (total 12 doses). All doses, including 31001074 and paroxetine will be administered at the same time (approximately 8 am), except on Day 13, when paroxetine will be administered 30 minutes (approximately 7:30 am) before the administration of 31001074.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Not yet recruiting
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Published on BioPortfolio: 2014-08-27T03:12:18-0400
This is an open-label (both the physician and healthy volunteer know which treatment will be administered) study to assess the pharmacokinetics (process by which JNJ-31001074 is absorbed, ...
This is an open-label (both the physician and healthy volunteer know which treatment will be administered), single-dose, 4-period study to characterize the pharmacokinetics (process by whi...
The purpose of this study is to evaluate the efficacy and safety/tolerability of 3 different dosages of JNJ-31001074 compared with placebo in adult patients with attention-deficit/hyperact...
The primary purpose of this study is to compare the steady-state pharmacokinetic profile of paroxetine CR (controlled-release) at the dosage of 25mg/day using the proposed final market ta...
The study was designed to describe the relationship between dose and pharmacokinetic parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR tablet (12.5 ...
It is unclear whether anxiety increases or decreases suicidal risk. This may contribute to the lack of guidance on which antidepressant medications are best for suicidal depressed patients who present...
Outside the context of overdose and serotonin syndrome, seizures and myoclonic movements attributed to selective serotonin reuptake inhibitors (SSRIs) are rare and poorly documented. We present a 77-y...
The interactions of the drugs amlodipine and paroxetine, which are prescribed respectively for treatment of hypertension and depression, with the metabolizing enzyme cytochrome CYP2B4 as the drug targ...
This study retrospectively investigated the effectiveness of paroxetine for the treatment of poststroke depression (PSD).Seventy patient cases with PSD were included in this study, and were assigned t...
A serotonin uptake inhibitor that is effective in the treatment of depression.
Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.
Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.
Surgical reinnervation of a denervated peripheral target using a healthy donor nerve and/or its proximal stump. The direct connection is usually made to a healthy postlesional distal portion of a non-functioning nerve or implanted directly into denervated muscle or insensitive skin. Nerve sprouts will grow from the transferred nerve into the denervated elements and establish contact between them and the neurons that formerly controlled another area.
Dietary patterns which have been found to be important in reducing disease risk.
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...