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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Canagliflozin 300 mg once daily and HCTZ 25 mg once daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT01294631

CR017851

28431754DIA1034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

001

Experimental group

Description:

Canagliflozin 300 mg once daily and HCTZ 25 mg once daily 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..

Treatment:

Drug: Canagliflozin 300 mg once daily and HCTZ 25 mg once daily