A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin (JNJ-28431754) in Healthy Indian Volunteers

NCT01748526 | Completed Phase 1

• 2 other identifiers: CR01498628431754DIA1008
• Study Type: interventional
• Target: 16
• 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 2 different doses of canagliflozin (JNJ-28431754) in healthy Indian volunteers.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Plasma concentrations of canagliflozin JNJ-28431754)

  Plasma concentrations of canagliflozin (JNJ-28431754), following the administration of a single 200mg dose and a single 300 mg dose, will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).

  Up to Day 4

• Urine concentrations of canagliflozin (JNJ-28431754)

  Urine concentrations of canagliflozin (JNJ-28431754), following the administration of a single 200mg dose and a single 300 mg dose, will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug).

  Up to Day 4

• Change from baseline in 24-hour urine glucose excretion

  Change from baseline in 24-hour urine glucose excretion following the administration of a single 200 mg dose and a single 300 mg dose of canagliflozin (JNJ-28431754) will be used to evaluate the pharmacodynamics of canagliflozin (ie, how the drug affects the body).

  Day -1 (Baseline) up to Day 3

• Change from baseline in the area under the plasma glucose concentration-time curve (AUC)

  Change from baseline in the area under the plasma glucose concentration-time curve (AUC) (a measure of the body's exposure to glucose) at 4 hours following the administration of a single 200mg dose and a single 300 mg dose of canagliflozin (JNJ-28431754) will be used to assess the pharmacodynamics of canagliflozin (ie, how the drug affects the body).

  Day -1 (Baseline) and 4 hours post-dose

• Change from baseline in the area under the plasma insulin concentration-time curve (AUC)

  Change from baseline in the area under the plasma insulin concentration-time curve (AUC) (a measure of the body's exposure to insulin) at 4 hours following the administration of a single 200mg dose and a single 300 mg dose of canagliflozin (JNJ-28431754) will be used to assess the pharmacodynamics of canagliflozin (ie, how the drug affects the body).

  Day -1 (Baseline) and 4 hours post-dose

• Change from baseline in the area under the plasma C-peptide concentration-time curve (AUC)

  Change from baseline in the area under the plasma C-peptide concentration-time curve (AUC) (a measure of the body's exposure to C-peptide) at 4 hours following the administration of a single 200mg dose and a single 300 mg dose of canagliflozin (JNJ-28431754) will be used to assess the pharmacodynamics of canagliflozin (ie, how the drug affects the body).

  Day -1 (Baseline) and 4 hours post-dose

Study Arms (2)

Treatment A

EXPERIMENTAL

Each volunteer will receive a single 200 mg dose of canagliflozin (JNJ-28431754) on Day 1.

Drug: Canagliflozin (JNJ-28431754) 200 mg

Treatment B

EXPERIMENTAL

Each volunteer will receive a single 300 mg dose of canagliflozin (JNJ-28431754) on Day 1.

Drug: Canagliflozin (JNJ-28431754) 300 mg

Interventions

Canagliflozin (JNJ-28431754) 200 mg DRUG

One 200 mg tablet taken orally (by mouth) on Day 1.

Also known as: JNJ-28431754

Treatment A

Canagliflozin (JNJ-28431754) 300 mg DRUG

One 300 mg tablet taken orally (by mouth) on Day 1.

Also known as: JNJ-28431754

Treatment B

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 18 and 35 kg/m2 (inclusive) and body weight not less than 50 kg
• Volunteer must have a glomerular filtration rate (the volume of fluid filtered by the kidney) more than or equal to 90 mL/min/1.73 m2 using the Modification of Diet in Renal Disease calculation
• Fasting blood glucose at screening must be less than 100 mg/dL and the 2 hour plasma glucose following the oral glucose tolerance test (conducted at screening) must be less than 140 mg/dL

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
• Female volunteer is breast-feeding
• Volunteer has a history of smoking or use of nicotine-containing substances within the previous 2 months

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Ahmedabad, India

Location

Related Publications (1)

• Devineni D, Polidori D, Curtin C, Stieltjes H, Tian H, Wajs E. Single-dose Pharmacokinetics and Pharmacodynamics of Canagliflozin, a Selective Inhibitor of Sodium Glucose Cotransporter 2, in Healthy Indian Participants. Clin Ther. 2016 Jan 1;38(1):89-98.e1. doi: 10.1016/j.clinthera.2015.11.008. Epub 2015 Dec 11.

  PMID: 26687552 DERIVED

Related Links

• A Single-Dose, Open-Label, Randomized, Two-Way, Cross-Over Study to Assess the Pharmacokinetics and Pharmacodynamics of JNJ-28431754 in Healthy Indian Subjects

MeSH Terms

Interventions

Canagliflozin

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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: August 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 19, 2016

Record last verified: 2016-07

Locations

IN (1)