Clinical trial NCT01791231: A Study to Investigate the Absorption, Metabolism, and Excretion of Canagliflozin (JNJ-28431754) in Healthy Male Volunteers
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Male
Canagliflozin (JNJ-28431754)
Radiolabeled 14C-canagliflozin
Absorption
Metabolism
Excretion
Radioactivity
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma concentrations of canagliflozin (JNJ-28431754)
timeFrame: Up to Day 3
measure: Urine concentrations of canagliflozin (JNJ-28431754)
timeFrame: Up to Day 14
measure: Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) excreted in urine
timeFrame: up to Day 14
measure: Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) excreted in feces
timeFrame: Up to Day 14
measure: Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) in blood
timeFrame: Up to Day 8
measure: Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) in plasma
timeFrame: Up to Day 8
measure: Concentrations of canagliflozin (JNJ-28431754) metabolites in plasma
timeFrame: Up to Day 14
measure: Concentrations of canagliflozin (JNJ-28431754) metabolites in urine
timeFrame: Up to Day 14
measure: Concentrations of canagliflozin (JNJ-28431754) metabolites in feces
timeFrame: Up to Day 14
Secondary outcomes:
measure: Number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to 5 weeks
Other outcomes:
Locations:
city: Merksem
country: Belgium
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: