A Phase 1 interventional study of Radiolabelled 14C-canagliflozin (14C-JNJ-28431754) in Healthy, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-29.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 1, Interventional, and Treatment
The purpose of this study is to investigate the absorption (the way the drug enters the body), metabolism (the way the drug is broken down in the body), and excretion (the way drug leaves the body) of canagliflozin (JNJ-28431754) in healthy male volunteers after a single dose of radiolabeled 14C-canagliflozin (14C-JNJ-28431754). The safety and tolerability of canagliflozin will also be assessed.
This study will be an open label (all volunteers and study staff know the identity of the assigned treatment), single dose, single center study to investigate the absorption, metabolism, and excretion of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus). The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of study (or follow-up) phase. On Day 1, all volunteers will receive a single oral dose of radiolabeled 14C-canagliflozin which contains 196 mg of canagliflozin and approximately 40 microcurie (1480kBq) of radioactivity. The International Commission on Radiological Protection considers this amount of radioactivity to be acceptable for this type of study. The radioactivity allows the amount of canagliflozin and its metabolites (break-down products) to be more precisely measured in blood, plasma, urine, and feces samples, which will be collected from each volunteer. The total duration of the study is approximately 5 weeks (including screening and follow-up); this time will be increased by 6 days in volunteers who have a slower rate of excretion of canagliflozin.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each volunteer will receive a single dose of radiolabelled 14C-canagliflozin (14C-JNJ-28431754) on Day 1.
Drug: Radiolabelled 14C-canagliflozin (14C-JNJ-28431754)
A single oral dose of 196 mg radiolabeled 14C-canagliflozin (14C-JNJ-28431754) liquid suspension containing approximately 40 microcurie (1480 kBq) of 14C radioactivity will be administered on Day 1.
Also known as: 14C-JNJ-28431754
Plasma concentrations of canagliflozin (JNJ-28431754)
Plasma concentrations of canagliflozin (JNJ-28431754) will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).
Time frame: Up to Day 3
Urine concentrations of canagliflozin (JNJ-28431754)
Urine concentrations of canagliflozin (JNJ-28431754) will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).
Time frame: Up to Day 14
Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) excreted in urine
The total radioactivity excreted in the urine will be expressed as a percentage of the administered dose of canagliflozin (JNJ-28431754) and will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).
Time frame: up to Day 14
Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) excreted in feces
The total radioactivity excreted in the feces will be expressed as a percentage of the administered dose of canagliflozin (JNJ-28431754) and will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).
Time frame: Up to Day 14
Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) in blood
The total radioactivity in blood will be used to determine pharmacokinetic parameters for canagliflozin (JNJ-28431754) (measurements describing how the body affects the drug).
Time frame: Up to Day 8
Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) in plasma
The total radioactivity in plasma will be used to determine pharmacokinetic parameters for canagliflozin (JNJ-28431754) (measurements describing how the body affects the drug).
Time frame: Up to Day 8
Concentrations of canagliflozin (JNJ-28431754) metabolites in plasma
Concentrations of canagliflozin (JNJ-28431754) metabolites in plasma will be used to investigate the metabolism of canagliflozin (the way the drug is broken down in the body).
Time frame: Up to Day 14
Concentrations of canagliflozin (JNJ-28431754) metabolites in urine
Concentrations of canagliflozin (JNJ-28431754) metabolites in urine will be used to investigate the metabolism of canagliflozin (the way the drug is broken down in the body).
Time frame: Up to Day 14
Concentrations of canagliflozin (JNJ-28431754) metabolites in feces
Concentrations of canagliflozin (JNJ-28431754) metabolites in feces will be used to investigate the metabolism of canagliflozin (the way the drug is broken down in the body).
Time frame: Up to Day 14
Number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to 5 weeks
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.