A Study to Evaluate of the Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 in Healthy Male Participants
- Registration Number
- NCT02049697
- Brief Summary
The purpose of this study is to investigate the absorption, metabolic pathways and excretion of JNJ-39823277 in healthy male adults after administration of a single oral dose of a 25 mg (0.5 mg/mL solution) of 14C-JNJ-39823277.
- Detailed Description
This is an open-label (all people know the identity of the intervention) and single-arm (group) study. The study consists of 3 phases including, the screening phase (within 3 weeks prior to the start of study medication), treatment phase (8 to 15 days), and the follow-up phase (up to 6 days after the discharge from the hospital). Approximately 6 participants will be receiving the 14C-JNJ-39823277 in the study. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study will be up to approximately 6 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
- Body mass index (BMI) between 20 and 30 kg/m2 (BMI will be calculated as weight [kg]/square of height [square meter])
- Had consistent bowel movement habit (approximately once per day) within 30 days before dosing
- No clinically significant laboratory and electrocardiogram abnormalities
- Exposure to radiation for professional or medical reasons (exception of dental x rays and plain chest x ray) within 1 year before study medication administration
- History of or current clinically significant medical illness
- Clinically significant abnormal laboratory values, physical examination
- Positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, or barbiturates at screening and on the study medication administration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 14C-JNJ-39823277 14C-JNJ-39823277 -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) of 14C-JNJ-39823277 in plasma Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose Mass Balance After an Oral Dose of 14C-JNJ-39823277 as Generated From Recovery of Total Radioactivity Excreted in Urine and Feces Predose and up to 168 hours post-dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 14C-JNJ-39823277 Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of 14C-JNJ-39823277 Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of Area under Curve (AUC) last and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Elimination Half-Life Period (T1/2) of 14C-JNJ-39823277 Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose T1/2 is the time measured for the plasma concentration to decrease by one-half of its original concentration. It is associated with the terminal rate-constant (lambda\[z\]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Time of observed maximum plasma concentration (Tmax) of 14C-JNJ-39823277 Predose; 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours post-dose The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Routes of 14C-JNJ-39823277 Elimination Measured Through Total Radioactivity Concentrations in Urine and Feces Predose and up to 168 hours post-dose Whole Blood and Plasma Partitioning of Total Radioactivity Through Measurement of Total Radioactivity Levels in Blood Predose; post-dose 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 120, and 168 hours Identification of Major Metabolites in Plasma, Urine, and Feces Predose and up to 168 hours post-dose
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events as a measure of safety and tolerabilty Up to 6 weeks