Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy Obese Volunteers

NCT01756404 | Completed Phase 1

• 2 other identifiers: CR01376528431754NAP1008
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of increasing doses of canagliflozin (JNJ-28431754) in healthy obese volunteers.

Conditions

Healthy

Keywords

Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Pharmacodynamics; Obesity

Outcome Measures

Primary Outcomes (4)

• Change from baseline in urine glucose excretion per day

  The change from baseline in urine excretion per day will be compared following escalating doses of canagliflozin (JNJ-28431754).

  Day -1 (Baseline) up to Day 17

• Change from baseline in urine glucose excretion per hour

  The change from baseline in urine excretion per hour will be compared following escalating doses of canagliflozin (JNJ-28431754).

  Day -1 (Baseline) up to Day 17

• Visual analog scale (VAS) scores related to hunger, satiety, fullness and prospective food consumption

  Visual analog scale (VAS) scores will be obtained from the VAS questionnaire. In the VAS questionnaire, volunteers mark a point on a line (drawn between 2 statements) to indicate how they feel about the statements. The statements about hunger are as follows: "I am not hungry at all" and "I have never been hungrier". Other statements relate to satiety (feeling satisfied), feeling full and prospective food consumption. Scores will be compared following escalating doses of canagliflozin (JNJ-28431754).

  Day -2 up to Day 17

• Change from baseline in mean 24-hour plasma glucose concentrations

  The change from baseline in mean 24-hour plasma glucose concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).

  Day -1 (Baseline) up to Day 16

Secondary Outcomes (6)

• Renal threshold for glucose excretion

  Up to Day 17

• Change from baseline in mean 24-hour plasma insulin concentrations

  Day -1 (Baseline) up to Day 14

• Change from baseline in mean 24-hour plasma C-peptide concentrations

  Day -1 (Baseline) up to Day 14

• Change from baseline in glucose excursions (after breakfast)

  Day -1 (Baseline) up to Day 14

• Change from baseline in insulin excursions (after breakfast)

  Day -1 (Baseline) up to Day 14

Study Arms (5)

Cohort 1

EXPERIMENTAL

Each volunteer will receive a total daily dose of 30 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.

Drug: Canagliflozin (JNJ-28431754); Drug: Placebo

Cohort 2

EXPERIMENTAL

Each volunteer will receive a total daily dose of 100 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.

Drug: Canagliflozin (JNJ-28431754); Drug: Placebo

Cohort 3

EXPERIMENTAL

Each volunteer will receive a total daily dose of 300 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.

Drug: Canagliflozin (JNJ-28431754); Drug: Placebo

Cohort 4

EXPERIMENTAL

Each volunteer will receive a total daily dose of 600 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.

Drug: Canagliflozin (JNJ-28431754); Drug: Placebo

Cohort 5

EXPERIMENTAL

Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) twice daily (600 mg total daily dose) or placebo (inactive medication) twice daily on Days 1 through 14.

Drug: Canagliflozin (JNJ-28431754); Drug: Placebo

Interventions

Canagliflozin (JNJ-28431754) DRUG

A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.

Also known as: JNJ-28431754

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Placebo DRUG

Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 18 Years - 60 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) of 30.0 to 39.9 kg/m2
• Volunteers must be non-diabetic as confirmed by fasting plasma glucose \<126 mg/dL
• Volunteers must be non-smoker or non-tobacco users (not smoked cigarettes or used tobacco-containing products for 3 months prior to screening)

You may not qualify if:

• 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 patient from the study or that could interfere with the interpretation of the study results
• History of having taken anti-obesity medications (prescription or non-prescription) within 3 months of the screening visit, or anticipates a need to take any of these drugs during the course of the study
• History of gastric banding, gastric bypass or other gastric-reduction surgery
• History of eating disorder or recent significant changes in body weight due to dieting or nutritional treatment

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Miramar, Florida, United States

Location

Related Links

• A Double-Blind, Randomized, Placebo-Controlled, Sequential Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of JNJ-28431754 in Otherwise Healthy Obese Male and Female Subjects.

MeSH Terms

Conditions

Obesity

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 25, 2012
• Study Start: June 14, 2007
• Primary Completion: December 5, 2007
• Study Completion: December 5, 2007
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

US (1)