Clinical trial NCT01748526: A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin (JNJ-28431754) in Healthy Indian Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Canagliflozin (JNJ-28431754)
Pharmacokinetics
Pharmacodynamics
Indian
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2012-12-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Plasma concentrations of canagliflozin JNJ-28431754)
timeFrame: Up to Day 4
measure: Urine concentrations of canagliflozin (JNJ-28431754)
timeFrame: Up to Day 4
measure: Change from baseline in 24-hour urine glucose excretion
timeFrame: Day -1 (Baseline) up to Day 3
measure: Change from baseline in the area under the plasma glucose concentration-time curve (AUC)
timeFrame: Day -1 (Baseline) and 4 hours post-dose
measure: Change from baseline in the area under the plasma insulin concentration-time curve (AUC)
timeFrame: Day -1 (Baseline) and 4 hours post-dose
measure: Change from baseline in the area under the plasma C-peptide concentration-time curve (AUC)
timeFrame: Day -1 (Baseline) and 4 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
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:
citation: Devineni D, Polidori D, Curtin C, Stieltjes H, Tian H, Wajs E. Single-dose Pharmacokinetics and Pharmacodynamics of Canagliflozin, a Selective Inhibitor of Sodium Glucose Cotransporter 2, in Healthy Indian Participants. Clin Ther. 2016 Jan 1;38(1):89-98.e1. doi: 10.1016/j.clinthera.2015.11.008. Epub 2015 Dec 11.