Clinical trial NCT02049697: A Study to Evaluate of the Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 in Healthy Male Participants
Official title: Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 (TPI 1062) After a Single Oral Dose in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Healthy male participants
14C-JNJ -39823277
TPI 1062
Tianeptine
Absorption
Metabolism
Excretion
Pharmacokinetics
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2014-01-30
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of 14C-JNJ-39823277 in plasma
timeFrame: 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
measure: Time of observed maximum plasma concentration (Tmax) of 14C-JNJ-39823277
timeFrame: 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
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 14C-JNJ-39823277
timeFrame: 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
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of 14C-JNJ-39823277
timeFrame: 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
measure: Elimination Half-Life Period (T1/2) of 14C-JNJ-39823277
timeFrame: 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
measure: Mass Balance After an Oral Dose of 14C-JNJ-39823277 as Generated From Recovery of Total Radioactivity Excreted in Urine and Feces
timeFrame: Predose and up to 168 hours post-dose
measure: Routes of 14C-JNJ-39823277 Elimination Measured Through Total Radioactivity Concentrations in Urine and Feces
timeFrame: Predose and up to 168 hours post-dose
measure: Whole Blood and Plasma Partitioning of Total Radioactivity Through Measurement of Total Radioactivity Levels in Blood
timeFrame: 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
measure: Identification of Major Metabolites in Plasma, Urine, and Feces
timeFrame: Predose and up to 168 hours post-dose
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerabilty
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Merksem
country: Belgium
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L C.Clinical Trial
role: STUDY_DIRECTOR
References: