A Study to Evaluate of the Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 in Healthy Male Participants
28 januari 2014 uppdaterad av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 (TPI 1062) After a Single Oral Dose in Healthy Male Subjects
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
6
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Merksem, Belgien
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 56 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 14C-JNJ-39823277
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Participants will receive a single oral dose of 25 mg 14C-JNJ-39823277 as a 50-mL solution.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Maximum observed plasma concentration (Cmax) of 14C-JNJ-39823277 in plasma
Tidsram: 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
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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
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Time of observed maximum plasma concentration (Tmax) of 14C-JNJ-39823277
Tidsram: 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
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The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
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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
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of 14C-JNJ-39823277
Tidsram: 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
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The AUClast is area under the plasma concentration-time curve from time zero to the last quantifiable concentration.
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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
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Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of 14C-JNJ-39823277
Tidsram: 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
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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.
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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
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Elimination Half-Life Period (T1/2) of 14C-JNJ-39823277
Tidsram: 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
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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).
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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
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Mass Balance After an Oral Dose of 14C-JNJ-39823277 as Generated From Recovery of Total Radioactivity Excreted in Urine and Feces
Tidsram: Predose and up to 168 hours post-dose
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Predose and up to 168 hours post-dose
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Routes of 14C-JNJ-39823277 Elimination Measured Through Total Radioactivity Concentrations in Urine and Feces
Tidsram: Predose and up to 168 hours post-dose
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Predose and up to 168 hours post-dose
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Whole Blood and Plasma Partitioning of Total Radioactivity Through Measurement of Total Radioactivity Levels in Blood
Tidsram: 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
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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
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Identification of Major Metabolites in Plasma, Urine, and Feces
Tidsram: Predose and up to 168 hours post-dose
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Predose and up to 168 hours post-dose
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Number of participants with adverse events as a measure of safety and tolerabilty
Tidsram: Up to 6 weeks
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Up to 6 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Johnson & Johnson Pharmaceutical Research & Development, L.L C.Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2009
Primärt slutförande (Faktisk)
1 maj 2009
Avslutad studie (Faktisk)
1 maj 2009
Studieregistreringsdatum
Först inskickad
28 januari 2014
Först inskickad som uppfyllde QC-kriterierna
28 januari 2014
Första postat (Uppskatta)
30 januari 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
30 januari 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 januari 2014
Senast verifierad
1 januari 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CR100588
- TPI1062DEP1005 (Annan identifierare: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
- 2009-010867-17 (EudraCT-nummer)
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