Clinical trial NCT02039245: Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose Combination
Official title: An Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics of Canagliflozin (JNJ-28431754) and Metformin Following Once-Daily Administration of 2 Canagliflozin/Metformin XR (150/1,000-mg) Fixed Dose Combination Tablets in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Canagliflozin
Metformin
INVOKANA®
Type 2 Diabetes Mellitus
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-01-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
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 evaluate the multiple dose pharmacokinetics of 2 Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination tablets (150 mg/1,000 mg each) following once-daily oral dosing in healthy participants.

Detailed description: This is an open-label (physicians and participants know the identity of the assigned treatment), multiple-dose, single-center, pharmacokinetic study of a fixed dose combination (FDC) of 150 mg/1,000 mg Canagliflozin/extended release Metformin (CANA/MET XR) tablets. The study will consist of 3 phases: a Screening Phase of approximately 3 weeks, an Open-Label Treatment Phase, (when the participants will be confined to the study center for 11 days), and a Follow-up Phase of about 10 days. The total duration of the study will be about 42 days for each participant. During the Open-Label Treatment Phase, approximately 12 healthy adult participants will receive a single oral dose of 2 CANA/MET XR tablets once daily for 7 days after a provided dinner. Participants will be required to fast from the end of lunch until the dinner (a period of at least 6.5 hours) on Days 1 and 7 only.

Eligibility criteria: Inclusion Criteria:

* Must sign an informed consent document indicating they understand the purpose of the study and procedures
* Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive
* Must have a body weight of not less than 50 kg
* Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
* Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)

Exclusion Criteria:

* History of or current clinically significant medical illness
* Use of any systemic prescription or nonprescription medication (including vitamins and herbal supplements)
* Known allergy to canagliflozin or metformin or any of the excipients of the formulation
* Known allergy to heparin or history of heparin induced thrombocytopenia
* History of smoking or use of nicotine-containing substances within the previous 2 months

Primary outcomes:
measure: Plasma concentration of canagliflozin following the dose of 2 CANA/MET XR FDC tablets
timeFrame: Day 1, Day 7
measure: Plasma concentration of metformin following the dose of 2 CANA/MET XR FDC tablets
timeFrame: Day 1, Day 7
Secondary outcomes:
measure: Percentage of participants with adverse events as a measure of safety and tolerability
timeFrame: Screening, up to Day 10 of the follow-up
Other outcomes:
Locations:
city: Neptune
country: United States
state: New Jersey
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: