A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin in Healthy Chinese Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01707316
First received: October 12, 2012
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754 (canagliflozin) and its main metabolites (break-down products) following 2 different doses of canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin will also be assessed.


Condition Intervention Phase
Healthy
Drug: Treatment A: Canagliflozin 100 mg
Drug: Treatment B: Canagliflozin 300 mg
Other: Treatment C: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of JNJ-28431754 (Canagliflozin) in Healthy Chinese Subjects

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Plasma concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose [ Time Frame: Up to Day 4 ] [ Designated as safety issue: No ]
    Plasma concentrations of canagliflozin and its major metabolites will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug) for canagliflozin and its major metabolites.

  • Urine concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose [ Time Frame: Up to Day 2 ] [ Designated as safety issue: No ]
    Urine concentrations of canagliflozin and its major metabolites will be used to determine pharmacokinetic parameters for canagliflozin and its major metabolites.


Secondary Outcome Measures:
  • Renal threshold for glucose excretion following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication) [ Time Frame: Up to Day 2 ] [ Designated as safety issue: No ]
    Renal threshold is defined as the plasma glucose concentration above which glucose is excreted in the urine.

  • Urine glucose excretion (UGE) following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication) [ Time Frame: Up to Day 2 ] [ Designated as safety issue: No ]
    UGE is equal to the amount of glucose excreted into the urine over defined time intervals.

  • Mean plasma glucose concentration following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication) [ Time Frame: Up to Day 2 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1: Treatment A-B-C
The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.
Drug: Treatment A: Canagliflozin 100 mg
Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.
Other Name: JNJ-28431754
Drug: Treatment B: Canagliflozin 300 mg
Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.
Other Name: JNJ-28431754
Other: Treatment C: Placebo
Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.
Experimental: Sequence 2: Treatment B-C-A
The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.
Drug: Treatment A: Canagliflozin 100 mg
Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.
Other Name: JNJ-28431754
Drug: Treatment B: Canagliflozin 300 mg
Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.
Other Name: JNJ-28431754
Other: Treatment C: Placebo
Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.
Experimental: Sequence 3: Treatment C-A-B
The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.
Drug: Treatment A: Canagliflozin 100 mg
Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.
Other Name: JNJ-28431754
Drug: Treatment B: Canagliflozin 300 mg
Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.
Other Name: JNJ-28431754
Other: Treatment C: Placebo
Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.

Detailed Description:

This study will be a double-blind (neither the Investigator nor volunteer knows the assigned treatment), randomized (the treatment is assigned by chance), placebo-controlled (one of the study treatments is inactive), single-dose, 3-way cross over study (all volunteers will receive each of the 3 treatments but in a different order) in healthy Chinese volunteers. Volunteers will be assigned to 1 of 3 treatment sequence groups (ABC, BCA, or CAB). The treatment sequence will be decided by randomization. Treatment A will be a single oral (by mouth) dose of 100 mg of canagliflozin. Treatment B will be a single oral dose of 300 mg of canagliflozin. Treatment C will be a single oral dose of placebo (inactive medication). Each treatment will be given during a treatment period of 5 days duration; each treatment period will be separated by a washout period (a time period with no medication) of at least 10 days. Canagliflozin is currently being investigated for the treatment of type 2 diabetes mellitus (T2DM).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers must be non-smokers for at least 6 months before first study drug administration
  • Volunteers must consume no more than 4 to 5 cups of coffee or tea or 8 cans of cola each day

Exclusion Criteria:

  • 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
  • Female volunteer is breast-feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707316

Locations
China
Beijing, China
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01707316     History of Changes
Other Study ID Numbers: CR100923, 28431754DIA1026
Study First Received: October 12, 2012
Last Updated: February 18, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Healthy
JNJ-28431754
Canagliflozin
Pharmacokinetics
Pharmacodynamics

ClinicalTrials.gov processed this record on April 17, 2014