Advertisement

Topics

A Single and Multiple Dose Study to Explore the Safety Of JNJ-40346527 In Healthy Volunteers

2014-08-27 03:16:28 | BioPortfolio

Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single and multiple doses of JNJ-40346527 in healthy volunteers. This study will also investigate the pharmacokinetics of JNJ-40346527 with and without food.

Description

JNJ-40346527 is an experimental drug that is being tested to see if it may be useful in treating of rheumatoid arthritis and other inflammatory diseases. This study will compare the effects (both good and bad) of JNJ-40346527 to those of placebo (which looks like the drug being studied but has no active ingredients) in healthy volunteers. This study will be the first study in which JNJ-40346527 is given to humans. This study is being conducted in three parts. Parts 1 and 2 are randomized (study drug will be assigned by chance), double-blind (neither the physician nor volunteer knows the identity of the assigned drug) studies comparing the safety and tolerability of JNJ-40346527 to placebo in 96 healthy volunteers. Part 3 is an open-label (all people involved know the identity of the assigned drug), 2-period crossover (meaning that volunteers will receive both treatments at different times) study of the effects of food on JNJ-40346527 in 8 healthy male volunteers. For Part 1, the participation period is a maximum of 64 days, including a screening visit, a 5-day in-clinic period and three follow-up visits. For Part 2, the participation period is a maximum of 83 days, including a screening visit, an 18-day in-clinic period and two follow-up visits. For Part 3, the participation period is a maximum of 59 days, including a screening visit, two 4-day in-clinic periods separated by a 7 day break, and a follow-up visit. For all three parts of the study, safety evaluations, which will include ECG (a cardiac function test), vital signs and monitoring of side-effects will be performed. Additionally, blood and urine samples will be collected for evaluation. Volunteers will participate in 1 of 3 parts; Part 1: volunteers will receive a single oral (by mouth) dose of JNJ-40346527 (10, 50, 150, 300, 600, or 1000mg) or placebo; Part 2: volunteers will receive oral doses of JNJ-40346527 (50, 150, 300, 500 or 750mg) or placebo once a day for 14 days; Part 3: volunteers will receive two oral doses of 150mg of JNJ-40346527 with and without food, with a 7-day break between doses.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Health

Intervention

JNJ-40346527/Placebo, JNJ-40346527/Placebo, JNJ-40346527

Location

Antwerp
Belgium

Status

Recruiting

Source

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:28-0400

Clinical Trials [3877 Associated Clinical Trials listed on BioPortfolio]

CSF1R Inhibitor JNJ-40346527 in Treating Participants With Relapsed or Refractory Acute Myeloid Leukemia

This phase II trial studies how well FMS inhibitor JNJ-40346527 works in treating participants with acute myeloid leukemia that has come back or does not respond to treatment. FMS inhibito...

Potential Health Effects of Aronia Intake

Intervention cross-over study during which participants receive standardized amounts of aronia berry tablets or placebo for three months, then wash out for three months, then aronia tablet...

Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.

Prebiotic Effects of Isomalto-oligosaccharide

The primary purpose of this study is to evaluate the effect of an IMO nutritional supplement on gut microbiome, gut health, and body weight. Two formulations of the supplement will be eva...

Back to Basics - Effects, Narratives and Routes of Administration of Open-label Placebo

To date, very little is known about the mechanisms of open-label placebo treatment and there is a lack in highly controlled experimental designs. Therefore, the planned project will test w...

PubMed Articles [14224 Associated PubMed Articles listed on BioPortfolio]

Placebo effects and racial and ethnic health disparities: an unjust and underexplored connection.

While a significant body of bioethical literature considers how the placebo effect might introduce a conflict between autonomy and beneficence, the link between justice and the placebo effect has been...

Placebo analgesia persists during sleep: An experimental study.

Although placebo analgesia is a well-recognized phenomenon with important clinical implications, the possibility that placebo effects occur during sleep has received little attention. This experimenta...

Prescribing Placebos: An Experimental Examination of the Role of Dose, Expectancies, and Adherence in Open-Label Placebo Effects.

Recent evidence indicates that placebo effects can occur even when patients know that they are taking a placebo, termed the open-label placebo effect.

Placebo effect on the health-related quality of life of inflammatory bowel disease patients: a systematic review with meta-analysis.

Placebo effect in health-related quality of life (HRQoL) of inflammatory bowel disease (IBD) patients has been poorly characterized. This systematic review and meta-analysis aimed to assess i) mean im...

Implications of Placebo and Nocebo Effects for Clinical Practice: Expert Consensus.

Placebo and nocebo effects occur in clinical or laboratory medical contexts after administration of an inert treatment or as part of active treatments and are due to psychobiological mechanisms such a...

Medical and Biotech [MESH] Definitions

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A center in the PUBLIC HEALTH SERVICE which is primarily concerned with the collection, analysis, and dissemination of health statistics on vital events and health activities to reflect the health status of people, health needs, and health resources.

Knowledge, attitudes, and associated behaviors which pertain to health-related topics such as PATHOLOGIC PROCESSES or diseases, their prevention, and treatment. This term refers to non-health workers and health workers (HEALTH PERSONNEL).

Men and women working in the provision of health services, whether as individual practitioners or employees of health institutions and programs, whether or not professionally trained, and whether or not subject to public regulation. (From A Discursive Dictionary of Health Care, 1976)

More From BioPortfolio on "A Single and Multiple Dose Study to Explore the Safety Of JNJ-40346527 In Healthy Volunteers"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Drug Discovery
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...

Nutrition
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...

Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...


Searches Linking to this Trial