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

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ClinicalTrials.gov Identifier: NCT02049697
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: 14C-JNJ-39823277 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 (TPI 1062) After a Single Oral Dose in Healthy Male Subjects
Study Start Date : April 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: 14C-JNJ-39823277 Drug: 14C-JNJ-39823277
Participants will receive a single oral dose of 25 mg 14C-JNJ-39823277 as a 50-mL solution.




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of 14C-JNJ-39823277 in plasma [ Time Frame: 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 ]
  2. Time of observed maximum plasma concentration (Tmax) of 14C-JNJ-39823277 [ Time Frame: 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.

  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 14C-JNJ-39823277 [ Time Frame: 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.

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

  5. Elimination Half-Life Period (T1/2) of 14C-JNJ-39823277 [ Time Frame: 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).

  6. Mass Balance After an Oral Dose of 14C-JNJ-39823277 as Generated From Recovery of Total Radioactivity Excreted in Urine and Feces [ Time Frame: Predose and up to 168 hours post-dose ]
  7. Routes of 14C-JNJ-39823277 Elimination Measured Through Total Radioactivity Concentrations in Urine and Feces [ Time Frame: Predose and up to 168 hours post-dose ]
  8. Whole Blood and Plasma Partitioning of Total Radioactivity Through Measurement of Total Radioactivity Levels in Blood [ Time Frame: 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 ]
  9. Identification of Major Metabolites in Plasma, Urine, and Feces [ Time Frame: Predose and up to 168 hours post-dose ]

Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerabilty [ Time Frame: Up to 6 weeks ]


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Ages Eligible for Study:   18 Years to 56 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049697


Locations
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Belgium
Merksem, Belgium
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L C.Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT02049697     History of Changes
Other Study ID Numbers: CR100588
TPI1062DEP1005 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
2009-010867-17 ( EudraCT Number )
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: January 30, 2014
Last Verified: January 2014

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Healthy
Healthy male participants
14C-JNJ -39823277
TPI 1062
Tianeptine
Absorption
Metabolism
Excretion
Pharmacokinetics