A Study to Assess the Absorption, Metabolism, and Routes of Excretion Following Oral Administration of (14C) Radiolabeled JNJ--42756493 to Healthy Male Participants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 30 - 55 |
Updated: | 10/25/2017 |
Start Date: | March 2016 |
End Date: | August 2016 |
An Open-Label Phase 1 Study to Determine the Absorption, Metabolism, and Routes of Excretion Following Oral Administration of (14C) Radiolabeled JNJ-42756493 to Healthy Male Subjects
The purpose of this study is to assess the absorption, metabolism, and excretion of
JNJ-42756493 in healthy male adult participants after administration of a single oral dose of
12 milligram (mg) of unlabeled JNJ-42756493 admixed with 14C JNJ-42756493.
JNJ-42756493 in healthy male adult participants after administration of a single oral dose of
12 milligram (mg) of unlabeled JNJ-42756493 admixed with 14C JNJ-42756493.
This is a single--center, open--label (The researchers and participants know the treatment
the participant is receiving) study. The study consists of 3 parts: Screening (35 days ),
Open-label Treatment Phase (Day 1 up to Day 14 or 28); and Follow-up (up to 30 days). Total
duration of the study is approximately 79 to 93 days. Plasma and urine will be collected for
determination of JNJ-42756493 concentrations. Participants will be primarily evaluated for
absorption, the metabolic pathways and the excretion of JNJ-42756493. Participants' safety
will be monitored throughout the study.
the participant is receiving) study. The study consists of 3 parts: Screening (35 days ),
Open-label Treatment Phase (Day 1 up to Day 14 or 28); and Follow-up (up to 30 days). Total
duration of the study is approximately 79 to 93 days. Plasma and urine will be collected for
determination of JNJ-42756493 concentrations. Participants will be primarily evaluated for
absorption, the metabolic pathways and the excretion of JNJ-42756493. Participants' safety
will be monitored throughout the study.
Inclusion Criteria:
- Willing to adhere to the prohibitions and restrictions specified in the protocol
- A man who is sexually active must agree to use a condom; and a man who is sexually
active with a woman of childbearing potential and has not had a vasectomy, must agree
to use a condom in combination with an adequate contraception method as deemed
appropriate by the investigator (example, double-barrier method, partner using
effective contraception [defined as hormonal contraception (pill, patch, injection),
intrauterine device, surgical sterilization] and to not donate sperm for 5 months
after receiving the study drug
- Body mass index (BMI; weight [kg]/height2 [m]2) between 18 and 30 kilogram per square
meter (kg/m2) (inclusive), and body weight not less than 50 kg
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, hepatic or renal insufficiency [creatinine clearance below
90 milliliter per minute (mL/min)], thyroid disease, neurologic or psychiatric
disease, infection, or any other illness that the investigator considers should
exclude the participant or that could interfere with the interpretation of the study
results
- History or current evidence of ophthalmic disorder, such as central serous retinopathy
or retinal vein occlusion, active wet age related macular degeneration, diabetic
retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as
keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or
ulceration
- Clinically significant abnormal physical examination, vital signs, or 12 lead
electrocardiogram (ECG) and clinically significant abnormal values for hematology,
clinical chemistry, or urinalysis at screening or at screening or at admission to the
study center as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal
supplements), except for acetaminophen, within 14 days before dosing is scheduled
until End-of-Study procedures
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of
Mental Disorders (4th edition) (DSM-IV) criteria within 5 years before screening or
positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates,
opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and
Day -2 of the treatment period.
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