Clinical trial NCT01273571: A Pharmacokinetic and Pharmacodynamic Study of Metformin and Canagliflozin in Healthy Adult Volunteers
Official title: An Open-Label, Fixed Sequence Study to Investigate the Potential for Pharmacokinetic and Pharmacodynamic Interaction Between Single-Dose Metformin and Multiple-Dose Canagliflozin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Canagliflozin
Metformin (GLUCOPHAGE IR)
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2011-01-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the potential interaction between multiple oral doses of canagliflozin and a single oral dose of metformin in healthy adult volunteers.

Detailed description: This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of canagliflozin and metformin in healthy adult volunteers. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) and metformin is an approved treatment for patients with T2DM. Canagliflozin will be administered orally (by mouth) as a single 300-mg tablet on Days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 1,000 mg tablets on Days 1 and 8. Both canagliflozin and metformin tablets will be taken with 8 ounces (240 mL) of water.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive.

Exclusion Criteria:

* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to canagliflozin or metformin or any of the excipients of the formulation of canagliflozin or metformin
* Known allergy to heparin or history of heparin induced thrombocytopenia.

Primary outcomes:
measure: Plasma concentrations of canagliflozin
timeFrame: At protocol-specified times up to Day 11
measure: Plasma concentrations of metformin
timeFrame: At protocol-specified times up to Day 11)
measure: Urine concentrations of metformin
timeFrame: At protocol-specified times up to Day 10)
measure: Plasma concentrations of glucose
timeFrame: Up to Day 9
measure: Urinary glucose excretion (UGE)
timeFrame: Up to Day 11
Secondary outcomes:
measure: The number and type of adverse events reported
timeFrame: Up to Day 8
Other outcomes:
Locations:
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:
citation: Devineni D, Manitpisitkul P, Murphy J, Skee D, Wajs E, Mamidi RN, Tian H, Vandebosch A, Wang SS, Verhaeghe T, Stieltjes H, Usiskin K. Effect of canagliflozin on the pharmacokinetics of glyburide, metformin, and simvastatin in healthy participants. Clin Pharmacol Drug Dev. 2015 May-Jun;4(3):226-36. doi: 10.1002/cpdd.166. Epub 2014 Oct 27.