A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin (JNJ-28431754) in Healthy Indian Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01748526
First received: December 10, 2012
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of 2 different doses of canagliflozin (JNJ-28431754) in healthy Indian volunteers.


Condition Intervention Phase
Healthy
Drug: Canagliflozin (JNJ-28431754) 200 mg
Drug: Canagliflozin (JNJ-28431754) 300 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Dose, Open-Label, Randomized, Two-Way, Cross-Over Study to Assess the Pharmacokinetics and Pharmacodynamics of JNJ-28431754 in Healthy Indian Subjects

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Plasma concentrations of canagliflozin JNJ-28431754) [ Time Frame: Up to Day 4 ] [ Designated as safety issue: No ]
    Plasma concentrations of canagliflozin (JNJ-28431754), following the administration of a single 200mg dose and a single 300 mg dose, will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).

  • Urine concentrations of canagliflozin (JNJ-28431754) [ Time Frame: Up to Day 4 ] [ Designated as safety issue: No ]
    Urine concentrations of canagliflozin (JNJ-28431754), following the administration of a single 200mg dose and a single 300 mg dose, will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).

  • Change from baseline in 24-hour urine glucose excretion [ Time Frame: Day -1 (Baseline) up to Day 3 ] [ Designated as safety issue: No ]
    Change from baseline in 24-hour urine glucose excretion following the administration of a single 200 mg dose and a single 300 mg dose of canagliflozin (JNJ-28431754) will be used to evaluate the pharmacodynamics of canagliflozin (ie, how the drug affects the body).

  • Change from baseline in the area under the plasma glucose concentration-time curve (AUC) [ Time Frame: Day -1 (Baseline) and 4 hours post-dose ] [ Designated as safety issue: No ]
    Change from baseline in the area under the plasma glucose concentration-time curve (AUC) (a measure of the body's exposure to glucose) at 4 hours following the administration of a single 200mg dose and a single 300 mg dose of canagliflozin (JNJ-28431754) will be used to assess the pharmacodynamics of canagliflozin (ie, how the drug affects the body).

  • Change from baseline in the area under the plasma insulin concentration-time curve (AUC) [ Time Frame: Day -1 (Baseline) and 4 hours post-dose ] [ Designated as safety issue: No ]
    Change from baseline in the area under the plasma insulin concentration-time curve (AUC) (a measure of the body's exposure to insulin) at 4 hours following the administration of a single 200mg dose and a single 300 mg dose of canagliflozin (JNJ-28431754) will be used to assess the pharmacodynamics of canagliflozin (ie, how the drug affects the body).

  • Change from baseline in the area under the plasma C-peptide concentration-time curve (AUC) [ Time Frame: Day -1 (Baseline) and 4 hours post-dose ] [ Designated as safety issue: No ]
    Change from baseline in the area under the plasma C-peptide concentration-time curve (AUC) (a measure of the body's exposure to C-peptide) at 4 hours following the administration of a single 200mg dose and a single 300 mg dose of canagliflozin (JNJ-28431754) will be used to assess the pharmacodynamics of canagliflozin (ie, how the drug affects the body).


Enrollment: 16
Study Start Date: August 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
Each volunteer will receive a single 200 mg dose of canagliflozin (JNJ-28431754) on Day 1.
Drug: Canagliflozin (JNJ-28431754) 200 mg
One 200 mg tablet taken orally (by mouth) on Day 1.
Other Name: JNJ-28431754
Experimental: Treatment B
Each volunteer will receive a single 300 mg dose of canagliflozin (JNJ-28431754) on Day 1.
Drug: Canagliflozin (JNJ-28431754) 300 mg
One 300 mg tablet taken orally (by mouth) on Day 1.
Other Name: JNJ-28431754

Detailed Description:

This study will be an open-label (all volunteers and study staff know the identity of the assigned treatment), randomized (the treatment is assigned by chance), single center, single dose, 2-way cross-over study (all volunteers switch from one treatment to another) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in healthy Indian volunteers. The study will consist of 3 phases: a single screening phase, a baseline phase of 2 days per period, and an open-label treatment phase that includes 2 treatment periods (Periods 1 and 2). During Period 1, volunteers will be randomly assigned to receive a single dose of either 200 mg (Treatment A) or 300 mg (Treatment B) of canagliflozin on Day 1. During Period 2, volunteers will receive the dose of canagliflozin (Treatment A or B) that they did not receive during Period 1. The duration of each treatment period will be 4 days and each treatment period will be separated by a 14 day washout period (when no medication is given). Each volunteer will participate in the study for approximately 45 days.

  Eligibility

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

Inclusion Criteria:

  • Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 18 and 35 kg/m2 (inclusive) and body weight not less than 50 kg
  • Volunteer must have a glomerular filtration rate (the volume of fluid filtered by the kidney) more than or equal to 90 mL/min/1.73 m2 using the Modification of Diet in Renal Disease calculation
  • Fasting blood glucose at screening must be less than 100 mg/dL and the 2 hour plasma glucose following the oral glucose tolerance test (conducted at screening) must be less than 140 mg/dL

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
  • Volunteer has a history of smoking or use of nicotine-containing substances within the previous 2 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748526

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01748526     History of Changes
Other Study ID Numbers: CR014986, 28431754DIA1008
Study First Received: December 10, 2012
Last Updated: January 8, 2013
Health Authority: India: The Drugs Controller General of India (DCGI)

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Healthy
Canagliflozin (JNJ-28431754)
Pharmacokinetics
Pharmacodynamics
Indian

ClinicalTrials.gov processed this record on April 22, 2014