A Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers

NCT01756417 | Completed Phase 1

• 2 other identifiers: CR01363628431754NAP1004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether there is a drug-drug interaction between multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety and tolerability of canagliflozin will also be assessed.

Conditions

Healthy

Keywords

Healthy; Canagliflozin (JNJ-28431754); Metformin; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (6)

• The maximum plasma concentration (Cmax) of canagliflozin (JNJ-28431754)

  Cmax (a measure of the body's exposure to canagliflozin \[JNJ-28431754\]) will be compared before and after administration of a single dose of metformin.

  Up to Day 8

• The area under the plasma concentration-time curve (AUC) for canagliflozin (JNJ-28431754)

  AUC (a measure of the body's exposure to canagliflozin \[JNJ-28431754\]) will be compared before and after administration of a single dose of metformin.

  Up to Day 8

• The maximum plasma concentration (Cmax) of metformin

  Cmax (a measure of the body's exposure to metformin will be compared before and after administration of multiple doses of canagliflozin (JNJ-28431754).

  Up to Day 8

• The area under the plasma concentration-time curve (AUC) for metformin

  AUC (a measure of the body's exposure to metformin will be compared before and after administration of multiple doses of canagliflozin (JNJ-28431754).

  Up to Day 8

• 24-hour urine glucose excretion

  24-hour urine glucose excretion will be compared following a single dose of metformin, multiple doses of canagliflozin (JNJ-28431754), or multiple doses of canagliflozin in combination with a single dose of metformin.

  Up to Day 10

• 24-hour area under the serum glucose concentration-time curve

  24-hour area under the serum glucose concentration-time curve will be compared following a single dose of metformin, multiple doses of canagliflozin (JNJ-28431754), or multiple doses of canagliflozin in combination with a single dose of metformin.

  Up to Day 8

Secondary Outcomes (1)

• The number of volunteers with adverse events as a measure of safety and tolerability

  up to 18 days

Study Arms (1)

Metformin + canagliflozin (JNJ-28431754)

EXPERIMENTAL

Each volunteer will receive a single dose of metformin on Day 1 followed by canagliflozin (JNJ-28431754) once daily on Days 4 to 7. On Day 8, volunteers will receive a single dose of canagliflozin in combination with a single dose of metformin.

Drug: Metformin; Drug: Canagliflozin (JNJ-28431754)

Interventions

Metformin DRUG

One 1,000 mg tablet of metformin taken orally (by mouth) on Day 1 and Day 8.

Metformin + canagliflozin (JNJ-28431754)

Canagliflozin (JNJ-28431754) DRUG

Four 25 mg tablets of canagliflozin (JNJ-28431754) taken orally on Days 4 through 8.

Also known as: JNJ-28431754

Metformin + canagliflozin (JNJ-28431754)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers must have a Body Mass Index (BMI \[weight (kg) / height (m)2\]) between 18.5 and 35 kg/m2, inclusive
• Volunteers must be non-smokers or non-tobacco users

You may not qualify if:

• \- History of or currently active illness that the Investigator considers to be clinically significant and should exclude the volunteer from the study or that could interfere with the interpretation of the study results

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Neptune City, New Jersey, United States

Location

Related Links

• An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of JNJ-28431754 in Healthy Male Subjects Following a Single Oral Dose Administration of 14C-JNJ-28431754

MeSH Terms

Interventions

Metformin; Canagliflozin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 25, 2012
• Study Start: October 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

US (1)