A Pharmacodynamics, Pharmacokinetics, and Safety Study of Hydrochlorothiazide and Canagliflozin in Healthy Volunteers

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Canagliflozin 300 mg once daily and HCTZ 25 mg once dailyDRUG

Period 1: canagliflozin tablets, oral, 300 mg, once daily on Days 1 to 7 followed 14 days later by Period 2. Period 2: HCTZ tablets, oral, 25 mg, once daily for Days 1 to 28 followed by canagliflozin tablets, oral, 300 mg, once daily taken with HCTZ tablets, oral 25 mg, once daily on Days 29 to 35..

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Urine glucose concentration

Time frame: At protocol-specified time points up to Day 36 in Period 2

Secondary Outcomes

Plasma concentration of canagliflozin

Time frame: Up to Day 36 in Period 2

Plasma concentration of hydrochlorothiazide (HCTZ)

Time frame: Up to Day 36 in Period 2

Plasma glucose concentration

Time frame: At protocol-specified time points up to Day 36 in Period 2

Blood pressure and heart rate measurements

Time frame: Up to Day 46 in Period 2

Plasma and urine electrolyte assessment

Time frame: Up to Day 36 in Period 2

The number and type of adverse events reported

Time frame: Up to Day 46 in Period 2

Data from ClinicalTrials.gov

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