Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose Combination

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039245
• Other study ID #: CR103255
• Secondary ID: 28431754DIA1042
• Status: Completed
• Phase: Phase 1
• First received: January 15, 2014
• Last updated: April 1, 2014
• Start date: January 2014
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CANA/MET XR FDC
Each tablet contains Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) of 150 mg/1,000 mg, to be taken orally (by mouth)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of canagliflozin following the dose of 2 CANA/MET XR FDC tablets	Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.	Day 1, Day 7	No
Primary	Plasma concentration of metformin following the dose of 2 CANA/MET XR FDC tablets	Plasma concentrations of metformin are used to evaluate how long it stays in the body.	Day 1, Day 7	No
Secondary	Percentage of participants with adverse events as a measure of safety and tolerability		Screening, up to Day 10 of the follow-up	No