Clinical trial NCT01756417: A Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers
Official title: An Open-Label, Fixed Sequence, Single and Multiple Dose Study in Male and Female Subjects to Investigate the Potential for Pharmacokinetic and Pharmacodynamic Interaction Between Metformin and JNJ-28431754
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Canagliflozin (JNJ-28431754)
Metformin
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2012-12-25
Enrollment: 18
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 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.

Detailed description: This study is an open-label (all volunteers and study staff know the identity of the assigned treatment), fixed sequence (all volunteers receive the same medication on the same days), single and multiple-dose study to determine how metformin (a blood glucose-lowering agent used to treat patients with diabetes) affects the pharmacokinetics (ie, how the body affects the drug) and the pharmacodynamics (ie, how the drug affects the body) of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus). The effect of canagliflozin on the pharmacokinetics and pharmacodynamics of metformin will also be evaluated. The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. Each volunteer will participate in the study for approximately 39 days.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- 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

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of canagliflozin (JNJ-28431754)
timeFrame: Up to Day 8
measure: The area under the plasma concentration-time curve (AUC) for canagliflozin (JNJ-28431754)
timeFrame: Up to Day 8
measure: The maximum plasma concentration (Cmax) of metformin
timeFrame: Up to Day 8
measure: The area under the plasma concentration-time curve (AUC) for metformin
timeFrame: Up to Day 8
measure: 24-hour urine glucose excretion
timeFrame: Up to Day 10
measure: 24-hour area under the serum glucose concentration-time curve
timeFrame: Up to Day 8
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to 18 days
Other outcomes:
Locations:
city: Neptune
country: United States
state: New Jersey
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: