A Study of 28431754 (Canagliflozin) on Gastrointestinal Glucose Absorption and Metabolism in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01173549
First received: July 29, 2010
Last updated: December 30, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to evaluate the effect of canagliflozin on gastrointestinal glucose absorption in healthy volunteers.


Condition Intervention Phase
Healthy
Drug: Canagliflozin/Placebo Placebo/Canagliflozin
Other: no intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: A Double-Blind, Randomized, Placebo Controlled, 2-Period Crossover Study to Evaluate the Effect of a Single Dose of JNJ-28431754 (Canagliflozin) on Gastrointestinal Glucose Absorption and Metabolism in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The amount of ingested glucose that is absorbed in systemic circulation [ Time Frame: During the first 1 and 2 hours after a standard mixed meal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The amount of ingested glucose that is absorbed in systemic circulation [ Time Frame: 2-6 hr and 0-6 hr after a standard mixed meal ] [ Designated as safety issue: No ]
  • Endogenous glucose production (EGP) [ Time Frame: At protocol-specified time points after a standard mixed meal ] [ Designated as safety issue: No ]
  • Total and incremental plasma glucose and insulin area under the curve (AUC) [ Time Frame: 0-1, 0-2, 2-6, and 0-6 hours after a standard mixed meal ] [ Designated as safety issue: No ]
  • Gastric emptying: peak level, time to peak level, and AUCs [ Time Frame: 0-6 hours after a standard mixed meal ] [ Designated as safety issue: No ]
  • Rate of Peripheral glucose disposal (Rd) [ Time Frame: At protocol-specified time points after a standard mixed meal ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: November 2010
Study Completion Date: September 2011
Arms Assigned Interventions
Experimental: 001
no intervention Part 1: 240 mL water 10 minutes (min) prior to the start of the MMTT on Day 1 of Periods 1 and 2. Periods 1 and 2 will be separated by 7 to 21 days.
Other: no intervention
Part 1: 240 mL water 10 minutes (min) prior to the start of the MMTT on Day 1 of Periods 1 and 2. Periods 1 and 2 will be separated by 7 to 21 days.
Experimental: 002
Canagliflozin/Placebo Placebo/Canagliflozin Part 2: 240 mL water 20 min prior to the MMTT on Day 1 of Periods 1 and 2 in each treatment sequence (1 dose of canagliflozin in Period 1 followed by 1 dose of placebo in Period 2 and then crossover to 1 dose of placebo in Period 1 followed by 1 dose of canagliflozin in Period 2).
Drug: Canagliflozin/Placebo Placebo/Canagliflozin
Part 2: 240 mL water 20 min prior to the MMTT on Day 1 of Periods 1 and 2 in each treatment sequence (1 dose of canagliflozin in Period 1 followed by 1 dose of placebo in Period 2 and then crossover to 1 dose of placebo in Period 1 followed by 1 dose of canagliflozin in Period 2).

Detailed Description:

This is a single center study that will be conducted in two Parts (Part 1 and Part 2) to evaluate the effect of a single-dose of canagliflozin on the absorption of glucose in healthy volunteers. Part 1 is a pilot (small) study where responses to key pharmocodynamic (PD) parameters (ie, specific tests on blood samples to evaluate effects of no treatment on the body) will be measured to confirm the study design and number of volunteers planned for Part 2. Part 2 is the main study where volunteers will be randomized (assigned to study drug or placebo by chance) to receive double-blind (neither the volunteer or study physician will know the identity of the treatment assigned) treatment with canagliflozin or placebo (treatment identical in appearance to canagliflozin but contains no active drug) to evaluate the effect of canagliflozin compared to placebo on gastrointestinal glucose absorption using a radiolabeled glucose tracer approach (ie, where a radioactive substance is combined with glucose allowing the movement of glucose in the body to be traced or detected). Blood and urine samples will be collected from volunteers at pre-defined times during the study for PD analysis. Safety will be monitored during the study by evaluating adverse events and results from clinical laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations performed. Volunteers in Part 1 will receive 240 ml of water 10 minutes before starting of the MMTT in each period (Periods 1 and 2). Volunteers in Part 2 will receive study drug 20 minutes prior to starting of the MMTT in treatment sequence 1 (a single 300-mg dose of canagliflozin in Period 1 followed by matching placebo in Period 2) or in treatment Sequence 2 (matching placebo in Period 1 followed by a single 300-mg dose of canagliflozin in Period 2). Periods 1 and 2 will be separated by 7 to 21 days.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a Body Mass Index (BMI) between 20 and 27 kg/m2 (inclusive) and a body weight not less than 50 kg
  • Be healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests performed at Screening and Admission
  • Agree (if men) to use a double barrier method of birth control (e.g., condom for them and use of spermacide with diaphragm, hormonal contraceptives or intrauterine devices by female partner) during the study and for three months following the last dose of study medication, and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
  • Willing/able to adhere to the prohibitions and restrictions specified in this protocol
  • Must have signed an informed consent form.

Exclusion Criteria:

  • Have a history of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant
  • Has been a smoker or tobacco user within the past 6 months
  • Have a history of recent major surgery (within 6 months of study start)
  • Tested positive for serology: hepatitis B surface antigen (HBsAg), hepatitis C antibodies (anti-HCV) or human immunodeficiency virus (HIV) antibodies
  • Fasting plasma glucose > 110 mg/dL
  • Have a history of alcohol or drug abuse within 2 years prior to Screening or a positive test for alcohol and/or drugs of abuse (including but not limited to barbiturates, opiates, cocaine, cannabinoids, amphetamines,MDMA (Ecstasy) and benzodiazepines) at Screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173549

Locations
United States, California
La Jolla, California, United States
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Physician, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01173549     History of Changes
Other Study ID Numbers: CR017224, 28431754DIA1022
Study First Received: July 29, 2010
Last Updated: December 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Canagliflozin
Pharmacodynamic
Glucose absorption
Glucose metabolism

ClinicalTrials.gov processed this record on October 23, 2014