Completed

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

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What is being tested

Radiolabelled 14C-canagliflozin (14C-JNJ-28431754)

Drug
Who is being recruted

From 18 to 45 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2007
See protocol details

Summary

Principal SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Last updated: June 29, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2007

Actual date on which the first participant was enrolled.

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.

NCT01791231
Principal SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Last updated: June 29, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Body Mass Index (BMI) (weight [kg]/height [m2]) between 18 and 30 kg/m2

Non-smoker

2 exclusion criteria prevent from participating
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Each volunteer will receive a single dose of radiolabelled 14C-canagliflozin (14C-JNJ-28431754) on Day 1.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Merksem, BelgiumOpen in Google Maps
CompletedOne Study Center