- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02218073
Pharmacokinetic Study of JNJ-42756493 in Healthy Participants
January 7, 2015 updated by: Janssen Research & Development, LLC
A Single-Dose, Open-Label, Randomized, Two-Way Crossover Pharmacokinetic Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Following Intake of a Tablet Versus a Solution and to Assess the Absolute Bioavailability of Orally Administered JNJ-42756493 Following Concomitant Administration of an Intravenous Microdose of the Stable Isotope JNJ-61818549 in Healthy Subjects
The purpose of this study is to evaluate the absolute bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-42756493 following a single 10 milligram (mg) dose as an oral solution administered in combination with a single intravenous administration of a microdose (100 microgram [mcg]) of JNJ-61818549 and to evaluate the relative bioavailability of 10 mg JNJ-42756493 following an oral solution (reference) and a tablet (test) formulation in a crossover (method used to switch subjects from one study group to another in a clinical trial) design in healthy participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized (study drug assigned by chance), open-label (all people know the identity of the intervention), 2-way crossover, single-dose, and single-center, Phase 1 study of oral JNJ-42756493 in healthy participants.
The duration of the study is approximately 36-63 days: 2-20 days Screening, two 7 days open-label treatment periods, 12-14 days washout and 12-14-day follow-up (Day 13-15 of period 2).
All participants will be randomly assigned to 1 of 2 treatment sequences.
In Treatment Sequence AB: JNJ-42756493 10 mg tablet formulation will be administered on Day 1 of Period 1 and 100 mcg JNJ-61818549 will be administered intravenously 2 hours after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 2. In Treatment Sequence BA: 100 mcg JNJ-61818549 will be administered intravenously after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 1 and 10 mg JNJ-42756493 tablet formulation will be administered on Day 1 of Period 2. A minimum 12 days washout is required between treatment periods.
Participants will primarily be analyzed for pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time).
Participants' safety will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Merksem, Belgium
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Received a thorough explanation of the optional pharmacogenomic research component of the study and was offered an opportunity to participate by signing the separate pharmacogenomic informed consent document
- If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), or surgically sterile
- If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening
- Body mass index (BMI) (weight kilogram [kg]/ height square meter[m^2] between 18 and 30 kg/m^2 (inclusive), and body weight not less than 50 kg
- Non-smoker for at least 6 months before entering the study
Exclusion Criteria:
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, metabolic bone disease (other than osteoporosis), infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening and predose on Day -2 (urinalysis only) and on Day -1 of both treatment Period as deemed appropriate by the investigator. Retesting of abnormal lab values that may lead to exclusion will be allowed once
- Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) at screening and Day -1 of both treatment Periods as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
- History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Sequence AB
Participants will receive 10 milligram (mg) JNJ-42756493 tablet orally on Day 1 of Period 1 and 100 microgram (mcg) of JNJ-61818549 as intravenous injection 2 hours after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 2.
|
Participants will be administered with 10 milligram (mg) JNJ-42756493 tablet orally either on Day 1 of Period 1 or on Day 1 of Period 2.
Participants will be administered with 10 mg JNJ-42756493 oral solution either on Day 1 of Period 1 or on Day 1 of Period 2.
Participants will receive 100 mcg of JNJ-61818549 as intravenous injection on Day 1 of Period 2 or Day 1 of Period 1.
|
Experimental: Treatment Sequence BA
Participants will receive 100 mcg of JNJ-61818549 as intravenous injection after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 1 and JNJ-42756493 10 mg tablet orally on Day 1 of Period 2.
|
Participants will be administered with 10 milligram (mg) JNJ-42756493 tablet orally either on Day 1 of Period 1 or on Day 1 of Period 2.
Participants will be administered with 10 mg JNJ-42756493 oral solution either on Day 1 of Period 1 or on Day 1 of Period 2.
Participants will receive 100 mcg of JNJ-61818549 as intravenous injection on Day 1 of Period 2 or Day 1 of Period 1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative Bioavailability: Maximum Plasma Concentration (Cmax)
Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
|
The Cmax is the maximum observed plasma concentration of JNJ-42756493.
|
Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
|
Absolute Bioavailability
Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
|
Absolute bioavailability will be measured by Area under concentration time-curve (AUC [0-24]), AUC (0-last) and AUC (0-infinity).
|
Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
|
Relative Bioavailability: Area under concententration time-curve (AUC)
Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
|
Relative bioavailability will be measured by AUC (0-24), AUC (0-last) and AUC (0-infinity).
|
Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Reach Maximum Concentration (tmax)
Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
|
The tmax is time to reach the maximum observed plasma concentration.
|
Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
|
Elimination Half-Life (t1/2)
Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
|
Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
|
Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
August 14, 2014
First Submitted That Met QC Criteria
August 14, 2014
First Posted (Estimate)
August 15, 2014
Study Record Updates
Last Update Posted (Estimate)
January 8, 2015
Last Update Submitted That Met QC Criteria
January 7, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CR104998
- 42756493EDI1002 (Other Identifier: Janssen Research & Development, LLC)
- 2014-002634-31 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on JNJ-42756493 10 mg tablet
-
Janssen Research & Development, LLCCompleted
-
Janssen Research & Development, LLCCompletedTumor or LymphomaUnited States, France, Spain
-
Janssen Research & Development, LLCCompleted
-
Janssen Research & Development, LLCTerminatedHepatic ImpairmentGermany
-
Janssen Research & Development, LLCCompletedNeoplasms | Lymphoma | Adenocarcinoma | Esophagogastric JunctionJapan
-
Janssen Research & Development, LLCTerminatedAlzheimer DiseaseFrance, Spain, Netherlands, Belgium, Germany, Sweden
-
Janssen Research & Development, LLCCompleted
-
Janssen-Cilag International NVCompleted
-
Janssen Pharmaceutical K.K.Completed
-
Johnson & Johnson Pharmaceutical Research & Development...TerminatedDiabetic NeuropathyUnited States