NCT01128985

A Pharmacokinetic and Pharmacodynamic Study to Determine Blood Levels of JNJ-28431754 (Canagliflozin) in Patients With Type 2 Diabetes Mellitus

A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Multiple Dose Pharmacokinetic and Pharmacodynamic Characteristics of JNJ-28431754 (Canagliflozin) in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics (blood levels of the drug) and pharmacodynamics (effects of the drug on the body) of canagliflozin after oral administration to patients with type 2 diabetes mellitus.

Detailed description

Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (patients will assigned to 1 of 4 study treatments by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), study to assess the pharmacokinetics (blood levels) and pharmacodynamics (effects of the drug on the body) of canagliflozin compared to a placebo (a capsule that looks like all the other treatments but has no real medicine) in patients with T2DM. Approximately 36 patients with T2DM will receive once-daily treatment with canagliflozin (50 mg, 100 mg, or 300 mg doses) or placebo for 7 days. Patients will participate in the study for approximately 9 weeks. Blood and urine samples will be collected at specified times before and after each dose of study drug for pharmacokinetic and pharmacodynamic analyses. A blood sample will also be collected before the first dose of study drug for pharmacogenomic analysis (ie, genetic testing) for possible use in characterizing the safety and/or efficacy of study drug in relation to the patient pharmacogenic profile. During the study, the safety and tolerability of canagliflozin will be evaluated by monitoring adverse events and findings from laboratory evaluations, vital signs measurements, and ECG measurements. The primary outcome measure in the study is the concentration of canagliflozin and its major metabolites (M5 and M7) in the blood measured by protocol-specified pharmacokinetic parameters at protocol specified time points through Day 7. Study drug will be taken orally (by mouth) once daily before the first meal each day. On Day -1, patients will take 1 dose of placebo in single-blind fashion (patient blinded) to determine baseline assessments. After randomization, patients will take single doses of double-blind canagliflozin (50 mg, 100 mg, or 300 mg) or matching placebo once daily for 7 days (Day 1 through Day 7).

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Canagliflozin 50 mg	50 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
DRUG	Canagliflozin 100 mg	100 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
DRUG	Canagliflozin 300 mg	300 mg capsule once daily for 7 consecutive days from Day 1 to Day 7.
DRUG	Placebo	matching canagliflozin placebo once daily for 7 consecutive days from Day 1 to Day 7

Timeline

• Start date: 2010-03-01
• Completion: 2010-07-01
• First posted: 2010-05-24
• Last updated: 2013-05-29

Locations

2 sites across 1 country: United States