Completed
Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-41443532 in Healthy Male and Female Caucasian and Male Japanese Subjects
Led by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Updated on 2014-04-08
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, tolerability pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and how it is removed from the body over time) and pharmacodynamics (the effects of the drug) of JNJ-41443532 in healthy male and female Caucasian and male Japanese participants.
CONDITIONS
Official Title
JNJ-41443532 Sex, Race, and Age Pharmacokinetic (PK) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Caucasian or Japanese male
- Japanese participant born in Japan of Japanese parents and maternal and paternal grandparents must not have lived outside of Japan for more than 5 years, and lifestyles including diet, must not have changed significantly since relocating from Japan
- Caucasian male or postmenopausal/surgically sterile Caucasian female
- Caucasian participant born of Caucasian parents and maternal and paternal grandparents must continue their usual lifestyle and diet
- Weight = 50 kilograms and Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive)
- Healthy on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG) and clinical laboratory tests performed at screening
- Men must agree to use a double barrier method of birth control (e.g. condom and use of spermicide with diaphragm, hormonal contraceptives or intrauterine devices by female partner) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Willing to adhere to the prohibitions and restrictions specified in this protocol
- Competency in speaking and comprehending the language where the study will be conducted
You will not qualify if you...
- History of, or currently active, significant illness or medical disorders, including (but not limited to) cardiovascular disease (including cardiac arrhythmias, myocardial infarction, stroke, peripheral vascular disease), endocrine or metabolic disease (e.g. hyper/hypo-thyroidism), hematological disease (e.g. von Willebrand's disease or other bleeding disorders), respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmologic disorders (including retinal disorders or cataracts), neoplastic disease, skin disorder, or any other illness that the Investigator considers should exclude the participant
- Participants at risk for QTc prolongation (specific heart rhythm irregularity)
- Within 12 months prior to screening, has had a clinically important, serious infection (e.g. hepatitis, pneumonia, or pyelonephritis), has been hospitalized for an infection or has been treated with intravenous (IV) antibiotics for an infection
- Smoker or tobacco user within the past 3 months
- History of alcohol or drug abuse
- History of clinically significant drug and/or food allergies, including allergies or intolerance (e.g. lactose intolerance)
- Donation of 1 or more units of blood or acute loss of an equivalent amount of blood within 60 days prior to study drug administration
- Received an experimental drug or used an experimental medical device within 60 days
Trial Site Locations
Total: 1 location
1
Cypress, California, United States
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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