A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin in Healthy Chinese Volunteers

NCT01707316 | Completed Phase 1

• 2 other identifiers: CR10092328431754DIA1026
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754 (canagliflozin) and its main metabolites (break-down products) following 2 different doses of canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin will also be assessed.

Conditions

Healthy

Keywords

Healthy; JNJ-28431754; Canagliflozin; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• Plasma concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose

  Plasma concentrations of canagliflozin and its major metabolites will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug) for canagliflozin and its major metabolites.

  Up to Day 4

• Urine concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose

  Urine concentrations of canagliflozin and its major metabolites will be used to determine pharmacokinetic parameters for canagliflozin and its major metabolites.

  Up to Day 2

Secondary Outcomes (3)

• Renal threshold for glucose excretion following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication)

  Up to Day 2

• Urine glucose excretion (UGE) following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication)

  Up to Day 2

• Mean plasma glucose concentration following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication)

  Up to Day 2

Study Arms (3)

Sequence 1: Treatment A-B-C

EXPERIMENTAL

The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.

Drug: Treatment A: Canagliflozin 100 mg; Drug: Treatment B: Canagliflozin 300 mg; Other: Treatment C: Placebo

Sequence 2: Treatment B-C-A

EXPERIMENTAL

The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.

Drug: Treatment A: Canagliflozin 100 mg; Drug: Treatment B: Canagliflozin 300 mg; Other: Treatment C: Placebo

Sequence 3: Treatment C-A-B

EXPERIMENTAL

The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.

Drug: Treatment A: Canagliflozin 100 mg; Drug: Treatment B: Canagliflozin 300 mg; Other: Treatment C: Placebo

Interventions

Treatment A: Canagliflozin 100 mg DRUG

Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.

Also known as: JNJ-28431754

Sequence 1: Treatment A-B-C; Sequence 2: Treatment B-C-A; Sequence 3: Treatment C-A-B

Treatment B: Canagliflozin 300 mg DRUG

Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.

Also known as: JNJ-28431754

Sequence 1: Treatment A-B-C; Sequence 2: Treatment B-C-A; Sequence 3: Treatment C-A-B

Treatment C: Placebo OTHER

Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.

Sequence 1: Treatment A-B-C; Sequence 2: Treatment B-C-A; Sequence 3: Treatment C-A-B

Eligibility Criteria

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

You may qualify if:

• Volunteers must be non-smokers for at least 6 months before first study drug administration
• Volunteers must consume no more than 4 to 5 cups of coffee or tea or 8 cans of cola each day

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Beijing, China

Location

Related Publications (1)

• Chen X, Hu P, Vaccaro N, Polidori D, Curtin CR, Stieltjes H, Sha S, Weiner S, Devineni D. Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Canagliflozin in Healthy Chinese Subjects. Clin Ther. 2015 Jul 1;37(7):1483-1492.e1. doi: 10.1016/j.clinthera.2015.04.015. Epub 2015 Jun 3.

  PMID: 26048186 DERIVED

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 16, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

CN (1)