A Pharmacokinetic and Bioavailability Study of 28431754 (Canagliflozin) in Healthy Male Volunteers
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ClinicalTrials.gov Identifier: NCT01157000 |
Recruitment Status
:
Completed
First Posted
: July 5, 2010
Last Update Posted
: April 8, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Canagliflozin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | An Open-Label, Single-Dose Study to Assess the Absolute Oral Bioavailability and Pharmacokinetics of JNJ-28431754 (Canagliflozin) Administered as a 300-mg Oral Tablet and an Intravenous Microdose of 10 mcg 14C-canagliflozin in Healthy Male Subjects |
Study Start Date : | May 2010 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 001
Canagliflozin On Day 1 all patients will receive a single 300-mg tablet of canagliflozin with 8 ounces of water followed 105 minutes later by a 15-minute intravenous infusion dose (15 mL) of 10 mcg of 14C-canagliflozin (200 nCi).
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Drug: Canagliflozin
On Day 1, all patients will receive a single 300-mg tablet of canagliflozin with 8 ounces of water followed 105 minutes later by a 15-minute intravenous infusion dose (15 mL) of 10 mcg of 14C-canagliflozin (200 nCi).
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- Protocol-specified pharmacokinetic parameters from blood samples to assess the absolute bioavailabilty of a 300-mg oral dose of canagliflozin [ Time Frame: Predose on Day 1 up to 72 hours postdose ]
- Protocol-specified pharmacokinetic parameters from blood samples to evaluate the pharmacokinetics of a single 300-mg oral dose of canagliflozin administered with a single 10-mcg intravenous dose of 14C canagliflozin [ Time Frame: Predose on Day 1 up to 72 hours postdose ]
- Measurement of 14C radioactivity from total urine and feces output to evaluate the extent of biliary excretion of a single 10-mcg intravenous dose of 14C canagliflozin [ Time Frame: Day 1 through 72 hours after initiation of the intravenous infusion ]
- The number and type of adverse events reported [ Time Frame: Time of screening up to 5 to 7 days after completion of all study related procedures on Day 4 ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
- agrees to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- has a blood pressure (after sitting for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
Exclusion Criteria:
- Used any 14C labeled medication within 6 months before the first dose of the study drug is scheduled
- Have history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Have clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening and at admission to the study center as deemed appropriate by the investigator
- Have clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening and admission to the study center as deemed appropriate by the investigator
- Used any prescription or nonprescription medication (including vitamins and herbal supplements), except for occasional use of paracetamol (a maximum of 3 doses per day of 500 mg paracetamol, and no more than 3 grams per week), within 14 days before the first dose of the study drug is scheduled

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): NCT01157000
Belgium | |
Merksem, Belgium |
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT01157000 History of Changes |
Other Study ID Numbers: |
CR017197 28431754DIA1021 |
First Posted: | July 5, 2010 Key Record Dates |
Last Update Posted: | April 8, 2014 |
Last Verified: | April 2014 |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Canagliflozin Pharmacokinetic Bioavailability |
Additional relevant MeSH terms:
Canagliflozin Hypoglycemic Agents Physiological Effects of Drugs |