Clinical trial NCT01294631: A Pharmacodynamics, Pharmacokinetics, and Safety Study of Hydrochlorothiazide and Canagliflozin in Healthy Volunteers
Official title: An Open-Label, Two-Period, Fixed-Sequence Study to Explore the Effects of Multiple Doses of Hydrochlorothiazide on the Pharmacodynamics, Pharmacokinetics, and Safety of Multiple Doses of Canagliflozin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Canagliflozin
JNJ-28431754
Hydrochlorothiazide
Pharmacokinetic
Pharmacodynamic
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 30
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 the study is to evaluate the effects of multiple doses of hydrochlorothiazide and canagliflozin on the concentrations of each drug in the blood and the concentration of glucose in the blood and urine in healthy adult volunteers.

Detailed description: This is a single-center, open-label study with 2 study periods where volunteers and study staff will know the names and doses of assigned study treatments. All volunteers will receive the same treatment. 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 hydrochlorothiazide (HCTZ) is a drug indicated for the treatment of patients with mild to moderate hypertension. During Period 1, volunteers will take canagliflozin 300 mg once daily for 7 days (Days 1 to 7) and during Period 2, volunteers will take HCTZ 25 mg once daily for 28 days (Days 1 to 28), and then starting on Day 29, will take canagliflozin 300 mg once daily and HCTZ 25 mg once daily for 7 days (Days 29 to 35). Period 1 and Period 2 will be separated by a minimum of 14 days.

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, and a body weight of not less than 50 kg

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 any of the excipients of the formulation of canagliflozin

Primary outcomes:
measure: Urine glucose concentration
timeFrame: At protocol-specified time points up to Day 36 in Period 2
Secondary outcomes:
measure: Plasma concentration of canagliflozin
timeFrame: Up to Day 36 in Period 2
measure: Plasma concentration of hydrochlorothiazide (HCTZ)
timeFrame: Up to Day 36 in Period 2
measure: Plasma glucose concentration
timeFrame: At protocol-specified time points up to Day 36 in Period 2
measure: Blood pressure and heart rate measurements
timeFrame: Up to Day 46 in Period 2
measure: Plasma and urine electrolyte assessment
timeFrame: Up to Day 36 in Period 2
measure: The number and type of adverse events reported
timeFrame: Up to Day 46 in Period 2
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, Vaccaro N, Polidori D, Rusch S, Wajs E. Effects of hydrochlorothiazide on the pharmacokinetics, pharmacodynamics, and tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in healthy participants. Clin Ther. 2014 May;36(5):698-710. doi: 10.1016/j.clinthera.2014.02.022. Epub 2014 Apr 13.