The purpose of the study is to investigate the absorption, metabolism, and excretion of 14C JNJ-38518168 in healthy adult male participants after a single oral dose of 30 mg 14C JNJ-38518168.
This is an open-label (all people know the identity of the intervention), single-center, single-arm (single group), and single-dose study. This study will include a screening period of 21 days prior to study medication administration. Six men will be enrolled and admitted to the clinical study unit on the morning of Day -1. On Day 1, participants will receive a single oral solution dose containing 30 mg of 14C JNJ-38518168 given as an oral solution. The participants will be confined to the clinical study unit for at least 360 hours after dosing ie, Day -1 through Day 14 and they will be discharged on Day 15; however, participants who, by Day 15, do not meet the discharge criteria will extend their residency in the study unit for up to Day 21. They will return to the study center 7 to 10 days after discharge for the final safety follow-up. The study will include the following safety evaluations: adverse event, vital sign, 12-lead electrocardiography, physical examination, and clinical laboratory test. For each participant the total duration in the study is approximately 6 weeks (including screening and safety follow-up) or 7 weeks for participants who extend the residence up to Day 21.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Following an at least 10-hour overnight fast, participants will receive a single dose containing 30 mg of 14C JNJ-38518168 given as an oral solution on Day 1
Unnamed facility
Merksem, Belgium
Maximum observed concentration of 14C JNJ-38518168 in plasma
Time frame: Predose; and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 336 hours post-dose
Time to reach the maximum observed concentration of 14C JNJ-38518168 in plasma
Time frame: Predose; and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 336 hours post-dose
Area under the concentration-time curve
Time frame: Predose; and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 336 hours post-dose
Amount of 14C JNJ-38518168 excreted into the urine during a collection interval
Amount excreted into the urine during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the urinary volume with the urinary concentration for that interval.
Time frame: Predose and from 0- to 4, 4- to 8, 8- to 12, 12- to 24, 24- to 36, 36- to 48 hours after dosing, and every 24 hours (pooled for 24-hour interval) thereafter until 336 hours post-dose
Amount of 14C JNJ-38518168 excreted into the feces during a collection interval
Amount excreted into the feces during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the feces weight with the feces concentration for that interval
Time frame: From Day -1 through Day 14
Amount excreted into the vomit during a collection interval (applicable only for participants who experience vomitting)
Amount excreted into the vomit during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the weight of the vomit with the vomit concentration for that interval
Time frame: Within 24 hours after dosing
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Number of participants with adverse events
Time frame: Up to 7 weeks