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

NCT01294631 | Completed Phase 1

• 2 other identifiers: CR01785128431754DIA1034
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Canagliflozin; JNJ-28431754; Hydrochlorothiazide; Pharmacokinetic; Pharmacodynamic

Outcome Measures

Primary Outcomes (1)

• Urine glucose concentration

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

Secondary Outcomes (6)

• Plasma concentration of canagliflozin

  Up to Day 36 in Period 2

• Plasma concentration of hydrochlorothiazide (HCTZ)

  Up to Day 36 in Period 2

• Plasma glucose concentration

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

• Blood pressure and heart rate measurements

  Up to Day 46 in Period 2

• Plasma and urine electrolyte assessment

  Up to Day 36 in Period 2

Study Arms (1)

001

EXPERIMENTAL

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..

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

Interventions

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

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..

001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (1)

• 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.

  PMID: 24726680 DERIVED

MeSH Terms

Interventions

Canagliflozin; Hydrochlorothiazide

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 11, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 16, 2012

Record last verified: 2012-10