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Completed

NCT Number: NCT02049697

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

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.

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Key information

Conditions

Healthy

Age range

18 year–56 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Merksem, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

14C-JNJ-39823277

Drug

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

Primary outcomes

  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 outcomes

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

    Time frame: Up to 6 weeks

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 (TPI 1062) After a Single Oral Dose in Healthy Male Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 30, 2014
Registry last updated
Jan 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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