A Study to Compare the Pharmacodynamics of Canagliflozin and Dapagliflozin in Healthy Volunteers

NCT01877889 | Completed Phase 1

• 3 other identifiers: CR10197428431754DIA10562013-000994-54
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the pharmacodynamics (ie, how the drug affects the body) of canagliflozin with the pharmacodynamics of dapagliflozin.

Conditions

Healthy

Keywords

Healthy; Canagliflozin; INVOKANA; Dapagliflozin; FORXIGA; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Between treatment difference in 24-hour mean renal threshold for glucose for canagliflozin (300 mg once daily for 4 days) compared to dapagliflozin (10 mg once daily for 4 days)

  Renal threshold is defined as the plasma glucose concentration above which glucose is excreted in the urine.

  Day 4

Secondary Outcomes (2)

• Percent change from baseline in postprandial glucose area under the curve at 0-2 hours post-dose on Day 4 following 300 mg of canagliflozin once daily for 4 days or 10 mg of dapagliflozin once daily for 4 days

  Day -10 (Baseline) and Day 4

• Number of volunteers with adverse events

  Up to Day 65

Study Arms (3)

Part 1: Cana

EXPERIMENTAL

Each volunteer will receive 300 mg of canagliflozin once daily for 4 days.

Drug: Canagliflozin

Part 2: Sequence 1 (Dapa/Cana)

EXPERIMENTAL

Each volunteer will receive 10 mg of dapagliflozin once daily for 4 days (treatment period 1) followed by 300 mg of canagliflozin once daily for 4 days (treatment period 2). Each treatment period will be separated by a 12- to 14-day washout period (with no medication).

Drug: Canagliflozin; Drug: Dapagliflozin

Part 2: Sequence 2 (Cana/Dapa)

EXPERIMENTAL

Each volunteer will receive 300 mg of canagliflozin once daily for 4 days (treatment period 1) followed by 10 mg of dapagliflozin once daily for 4 days (treatment period 2). Each treatment period will be separated by a 12- to 14-day washout period.

Drug: Canagliflozin; Drug: Dapagliflozin

Interventions

Canagliflozin DRUG

One 300 mg over-encapsulated tablet taken orally (by mouth) once daily for 4 days during Part 1 and Part 2 (Sequence 1 \[treatment period 2\] or Sequence 2 \[treatment period 1\]).

Also known as: Invokana

Part 1: Cana; Part 2: Sequence 1 (Dapa/Cana); Part 2: Sequence 2 (Cana/Dapa)

Dapagliflozin DRUG

One 10 mg over-encapsulated tablet taken orally once daily for 4 days during Part 2 (Sequence 1 \[treatment period 1\] or Sequence 2 \[treatment period 2\]).

Also known as: Forxiga

Part 2: Sequence 1 (Dapa/Cana); Part 2: Sequence 2 (Cana/Dapa)

Eligibility Criteria

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

You may qualify if:

• Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 20 and 27 kg/m2 (inclusive), and body weight \>= 50 kg at Screening
• Volunteers must have a systolic blood pressure between 90 and 140 mmHg, inclusive, and a diastolic blood pressure no higher than 90 mmHg (based upon an average of 3 blood pressure readings at Screening)
• Volunteers must be non-smokers

You may not qualify if:

• Major surgery (eg, requiring general anesthesia) within 12 weeks before Screening, or planned during participation in the study, or within 2 weeks after the last dose of study drug administration, or volunteer will not have fully recovered from surgery during participation in the study; volunteers with planned surgical procedures to be conducted under local anesthesia may participate
• History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening
• History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening
• History of, or currently active illness, considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the volunteer from the study or that could interfere with the interpretation of the study results

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (1)

Unknown Facility

Neuss, Germany

Location

MeSH Terms

Interventions

Canagliflozin; dapagliflozin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 14, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

DE (1)