A Study to Investigate the Absorption, Metabolism, and Excretion of Canagliflozin (JNJ-28431754) in Healthy Male Volunteers

An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of JNJ-28431754 in Healthy Male Subjects Following a Single Oral Dose Administration of 14C-JNJ-28431754

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Radiolabelled 14C-canagliflozin (14C-JNJ-28431754)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Merksem, Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 months
• History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiolabeled 14C-canagliflozin; 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.; Other Names: 14C-JNJ-28431754

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	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).	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).	Up to Day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of volunteers with adverse events as a measure of safety and tolerability	up to 5 weeks

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of JNJ-28431754 in Healthy Male Subjects Following a Single Oral Dose Administration of 14C-JNJ-28431754

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: February 12, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 13, 2013

Study Record Updates

• Last Update Posted (Estimate): June 29, 2016
• Last Update Submitted That Met QC Criteria: June 28, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Healthy; Male; Absorption; Metabolism; Excretion; Canagliflozin (JNJ-28431754); Radioactivity; Radiolabeled 14C-canagliflozin
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Canagliflozin
• Other Study ID Numbers: CR013624; 28431754NAP1006 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.); 2007-004218-15 (EudraCT Number)