JNJ-41443532 Sex, Race, and Age Pharmacokinetic (PK) Study

NCT01105780 | Completed Phase 1

• 2 other identifiers: CR01708341443532EDI1002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Healthy

Keywords

Healthy Volunteers; Healthy; Japanese; Pharmacokinetics; JNJ-41443532

Outcome Measures

Primary Outcomes (1)

• Determine the pharmacokinetic properties of a single dose JNJ-41443532 as determined by blood level concentrations.

  6 Weeks

Secondary Outcomes (3)

• To explore the pharmacodynamic (PD) effects of JNJ-41443532 and to compare differences in the PD profile by age, sex, and race.

  6 Weeks

• To explore the relationship between JNJ-41443532 plasma concentrations (blood levels) and pharmacodynamic effects (concentration-effect relationships).

  6 Weeks

• Determine the safety and tolerability of JNJ-41443532 as determined by evaluation of adverse events, lab results, cardiac monitoring, vital signs, and physical exams.

  6 Weeks

Study Arms (2)

001

EXPERIMENTAL

JNJ-41443532 250mg tablet once daily for 1 day

Drug: JNJ-41443532

002

PLACEBO COMPARATOR

Placebo Matching placebo

Drug: Placebo

Interventions

Placebo DRUG

Matching placebo

002

JNJ-41443532 DRUG

250mg tablet once daily for 1 day

001

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Cypress, California, United States

Location

MeSH Terms

Interventions

JNJ-41443532

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 16, 2010
• Study Start: May 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

US (1)