A Pharmacokinetic and Bioavailability Study of 28431754 (Canagliflozin) in Healthy Male Volunteers

NCT01157000 | Completed Phase 1

• 2 other identifiers: CR01719728431754DIA1021
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the absolute oral bioavailability (how fast and how much study drug is absorbed in the body) of a single 300-mg oral dose of canagliflozin in healthy male volunteers.

Conditions

Healthy

Keywords

Canagliflozin; Pharmacokinetic; Bioavailability

Outcome Measures

Primary Outcomes (1)

• Protocol-specified pharmacokinetic parameters from blood samples to assess the absolute bioavailabilty of a 300-mg oral dose of canagliflozin

  Predose on Day 1 up to 72 hours postdose

Secondary Outcomes (3)

• 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

  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

  Day 1 through 72 hours after initiation of the intravenous infusion

• The number and type of adverse events reported

  Time of screening up to 5 to 7 days after completion of all study related procedures on Day 4

Study Arms (1)

001

EXPERIMENTAL

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).

Drug: Canagliflozin

Interventions

Canagliflozin DRUG

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).

001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

Related Publications (1)

• Devineni D, Murphy J, Wang SS, Stieltjes H, Rothenberg P, Scheers E, Mamidi RN. Absolute oral bioavailability and pharmacokinetics of canagliflozin: A microdose study in healthy participants. Clin Pharmacol Drug Dev. 2015 Jul;4(4):295-304. doi: 10.1002/cpdd.162. Epub 2014 Dec 11.

  PMID: 27136910 DERIVED

MeSH Terms

Interventions

Canagliflozin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 5, 2010
• Study Start: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

BE (1)