Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of Single and Multiple Ascending Doses of JNJ-41443532 in Healthy Male Participants

NCT01106469 | Completed Phase 1

• 2 other identifiers: CR01706541443532EDI1001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety, tolerability, food effect as well as the 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 single and multiple ascending doses of JNJ-41443532 in healthy male participants.

Conditions

Healthy

Keywords

Healthy Volunteers; Healthy; JNJ-41443532; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Determine the pharmacokinetic properties of single and multiple doses JNJ-41443532 as determined by blood level concentrations.

  Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks

Secondary Outcomes (3)

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

  Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks

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

  Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks

• To explore the pharmacodynamic (PD) effects of JNJ-41443532 and to compare the differences between treatment groups

  Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks

Study Arms (7)

001

EXPERIMENTAL

JNJ-41443532 25mg tablet once daily

Drug: JNJ-41443532

002

EXPERIMENTAL

JNJ-41443532 100mg tablet once daily

Drug: JNJ-41443532

003

EXPERIMENTAL

JNJ-41443532 250mg tablet once daily

Drug: JNJ-41443532

004

EXPERIMENTAL

JNJ-41443532 500mg once daily (with 250mg tablets)

Drug: JNJ-41443532

005

EXPERIMENTAL

JNJ-41443532 1000mg once daily (with 250mg tablets)

Drug: JNJ-41443532

006

EXPERIMENTAL

JNJ-41443532 1500mg once daily (with 250mg tablets)

Drug: JNJ-41443532

007

PLACEBO COMPARATOR

Placebo Matching placebo

Drug: Placebo

Interventions

JNJ-41443532 DRUG

25mg tablet once daily

001

Placebo DRUG

Matching placebo

007

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males, age 18 to 45 years inclusive for Part 1 and age 18 to 55 years inclusive for Parts 2, 3, and 4
• Weight = 60 kilograms and Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive)
• BMI between 30 to 39.9 kg/m2 for obese participants
• Healthy on the basis of physical examination, medical history, vital signs, 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

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

Merksem, Belgium

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 20, 2010
• Study Start: February 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

BE (1)