Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01791231 | A Study to Investigate the Absorption, Metabolism, and Excretion of Canagliflozin (JNJ-28431754) in Healthy Male Volunteers | PHASE1 | COMPLETED | 6 | — | — | Aug 1, 2007 | Oct 1, 2007 | Jun 29, 2016 | 1 | Belgium |
Plasma concentrations of canagliflozin (JNJ-28431754) will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).
Urine concentrations of canagliflozin (JNJ-28431754) will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).
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).
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).
The total radioactivity in blood will be used to determine pharmacokinetic parameters for canagliflozin (JNJ-28431754) (measurements describing how the body affects the drug).
The total radioactivity in plasma will be used to determine pharmacokinetic parameters for canagliflozin (JNJ-28431754) (measurements describing how the body affects the drug).
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).
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).
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).
| Arm | Type | Description |
|---|---|---|
| Radiolabeled 14C-canagliflozin | EXPERIMENTAL | Each volunteer will receive a single dose of radiolabelled 14C-canagliflozin (14C-JNJ-28431754) on Day 1. |
| Name | Type | Description |
|---|---|---|
| Radiolabelled 14C-canagliflozin (14C-JNJ-28431754) | DRUG | 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. |
Inclusion Criteria: * Body Mass Index (BMI) (weight \[kg\]/height \[m2\]) between 18 and 30 kg/m2 * Non-smoker Exclusion Criteria: * Exposure to radiation for professional or medical reasons (except dental x-rays and x-rays of thorax and bone skeleton, excluding spinal column) in the past 12 mont...