Pharmacokinetics of a Fixed Dose Combination of Canagliflozin/Metformin Coadministered With Food

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: CANA/MET XR FDC

• Registration Number: NCT02039258
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

The purpose of this study is to assess the effect of coadministration of a high-fat meal on the oral bioavailability of a fixed dose combination of Canagliflozin/extended release Metformin (CANA/MET XR) tablet, containing 150 mg CANA and 1,000 mg extended release MET in healthy participants.

Detailed Description

This is a randomized (a sequence of fasted and fed periods accompanying study drug intake will be assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 2-period, 2-sequence, crossover study of Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) tablet of 150 mg/1,000 mg. Approximately 24 healthy adult participants will be enrolled to ensure that at least 20 complete the study.

After a screening period, participants will be randomly assigned to 1 of the 2 treatment sequences (AB or BA) on Day 1 of Period 1. Treatment A means a participant will receive a single 150/1,000 mg CANA/MET XR FDC tablet under fasted conditions, and Treatment B means that a participant will receive the same drug under fed conditions. Participants will need to remain at the study center for 4 days (72 hours postdose) after the drug administration for collection of blood samples in each treatment period. There will be a 10- to 14-day washout period between Period 1 and Period 2. On Day 4 (72 hours postdose) of Period 2, when participants are discharged from the study center, they will be given instructions to return for a follow-up visit 7 to 10 days later. For Treatment B (in fed state), participants will be provided with a standardized high-fat breakfast. Participants' safety will be monitored throughout the study.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-17
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 prescription or nonprescription medication (including vitamins and herbal supplements)
• History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose- 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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence AB	CANA/MET XR FDC	A single dose of CANA/MET XR FDC tablet of 150 mg/1,000 mg under fasted conditions (treatment A) followed by the same single dose under fed conditions (treatment B).
Sequence BA	CANA/MET XR FDC	A single dose of CANA/MET XR FDC tablet of 150 mg/1,000 mg under fed conditions (treatment B) followed by the same single dose under fasted conditions (treatment A).

Primary Outcome Measures

Name	Time	Method
Plasma concentration of canagliflozin following the single dose of CANA/MET XR FDC after fed and fasted conditions	Predose, (before tablet intake) up to 72 hours afterdose	Plasma concentrations of canagliflozin are used to evaluate how long canagliflozin stays in the body.
Plasma concentration of metformin following the single dose of CANA/MET XR FDC after fed and fasted conditions	Predose, up to 72 hours afterdose	Plasma concentrations of metformin are used to evaluate how long metformin stays in the body.

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with adverse events as a measure of safety and tolerability	Screening, up to Day 10 of the follow-up period