A Study to Evaluate of the Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 in Healthy Male Participants

NCT02049697 | Completed Phase 1 DMC

• 3 other identifiers: CR100588TPI1062DEP10052009-010867-17
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; Healthy male participants; 14C-JNJ -39823277; TPI 1062; Tianeptine; Absorption; Metabolism; Excretion; Pharmacokinetics

Outcome Measures

Primary Outcomes (9)

• 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

• Time of observed maximum plasma concentration (Tmax) of 14C-JNJ-39823277

  The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  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

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 14C-JNJ-39823277

  The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.

  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

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of 14C-JNJ-39823277

  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.

  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

• Elimination Half-Life Period (T1/2) of 14C-JNJ-39823277

  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).

  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

• 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 Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerabilty

  Up to 6 weeks

Study Arms (1)

14C-JNJ-39823277

EXPERIMENTAL

Drug: 14C-JNJ-39823277

Interventions

14C-JNJ-39823277 DRUG

Participants will receive a single oral dose of 25 mg 14C-JNJ-39823277 as a 50-mL solution.

14C-JNJ-39823277

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L C.Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 30, 2014
• Study Start: April 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: January 30, 2014

Record last verified: 2014-01

Locations

BE (1)