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Radiolabelled 14C-canagliflozin

Phase 1

Undisclosed | Small molecule | Other |Johnson & Johnson|Trials Updated: Jun 29, 2016

Radiolabelled 14C-canagliflozin target and mechanism

ModalitySmall molecule

Also known as Radiolabelled 14C-canagliflozin (14C-JNJ-28431754)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Radiolabelled 14C-canagliflozin clinical trials

Radiolabelled 14C-canagliflozin · 1 trial · 1 indication

Phase 1 1
NCT01791231A Study to Investigate the Absorption, Metabolism, and Excretion of Canagliflozin (JNJ-28431754) in Healthy Male VolunteersHealthy
COMPLETED6 Analytics
PHASE1COMPLETED
A Study to Investigate the Absorption, Metabolism, and Excretion of Canagliflozin (JNJ-28431754) in Healthy Male Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Plasma concentrations of canagliflozin (JNJ-28431754)
Up to Day 3

Plasma concentrations of canagliflozin (JNJ-28431754) will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).

Urine concentrations of canagliflozin (JNJ-28431754)
Up to Day 14

Urine concentrations of canagliflozin (JNJ-28431754) will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).

Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) excreted in urine
up to Day 14

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).

Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) excreted in feces
Up to Day 14

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).

Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) in blood
Up to Day 8

The total radioactivity in blood will be used to determine pharmacokinetic parameters for canagliflozin (JNJ-28431754) (measurements describing how the body affects the drug).

Total radioactivity of 14C-canagliflozin (14C-JNJ-28431754) in plasma
Up to Day 8

The total radioactivity in plasma will be used to determine pharmacokinetic parameters for canagliflozin (JNJ-28431754) (measurements describing how the body affects the drug).

Concentrations of canagliflozin (JNJ-28431754) metabolites in plasma
Up to Day 14

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).

Concentrations of canagliflozin (JNJ-28431754) metabolites in urine
Up to Day 14

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).

Concentrations of canagliflozin (JNJ-28431754) metabolites in feces
Up to Day 14

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).

Secondary Endpoints

Number of volunteers with adverse events as a measure of safety and tolerability
up to 5 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
Radiolabelled 14C-canagliflozin (14C-JNJ-28431754)DRUGA 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.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 mont...

Countries:Belgium
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Frequently asked questions about Radiolabelled 14C-canagliflozin

What is Radiolabelled 14C-canagliflozin?

Radiolabelled 14C-canagliflozin is a carbon-14 labeled form of canagliflozin, a small molecule developed by Johnson & Johnson. It is used in clinical research to study how the body absorbs, metabolizes, and excretes canagliflozin. It is not a marketed therapeutic product and is not approved for any indication.

Who makes Radiolabelled 14C-canagliflozin?

Radiolabelled 14C-canagliflozin is developed by Johnson & Johnson, which trades under the ticker JNJ. The compound is a radiolabeled research form of canagliflozin, also known as JNJ-28431754, and was studied in a company-sponsored clinical trial.

What phase is Radiolabelled 14C-canagliflozin in?

Radiolabelled 14C-canagliflozin is in Phase 1 development. It has been evaluated in a single completed Phase 1 study, and no active trials are ongoing. It is an investigational research compound and is not approved by the FDA for any use.

What clinical trials is Radiolabelled 14C-canagliflozin in?

Radiolabelled 14C-canagliflozin has been studied in one completed Phase 1 trial, NCT01791231, titled a study to investigate the absorption, metabolism, and excretion of canagliflozin (JNJ-28431754) in healthy male volunteers. The trial enrolled 6 participants in Belgium and has completed.

Is Radiolabelled 14C-canagliflozin the same as 14C-JNJ-28431754?

Yes. Radiolabelled 14C-canagliflozin is also known as 14C-JNJ-28431754. Both names refer to the same carbon-14 labeled research form of canagliflozin, the small molecule developed by Johnson & Johnson for studying drug absorption, metabolism, and excretion.