A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers

NCT01286103 | Completed Phase 1

• 2 other identifiers: CR01782428431754DIA1032
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing regimen in healthy adult volunteers

Conditions

Healthy

Keywords

Canagliflozin; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (4)

• Plasma concentrations of canagliflozin

  Up to Day 5 after the last treatment

• Plasma concentrations of glucose

  Up to Day 5 after the last treatment

• Urinary glucose excretion (UGE)

  Up to Day 5 after the last treatment

• Renal threshold of glucose (RTG)

  Up to Day 5 after the last treatment

Secondary Outcomes (3)

• The number and type of adverse events reported

  Up to 10 days after last dose (last dose is given on Day 8)

• Changes in hematology laboratory parameters

  Up to 10 days after last dose (last dose is given on Day 8)

• Changes in chemistry laboratory parameters

  Up to 10 days after last dose (last dose is given on Day 8)

Study Arms (2)

001

EXPERIMENTAL

Canagliflozin 300 mg once daily and 150 mg twice daily Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.

Drug: Canagliflozin 300 mg once daily and 150 mg twice daily

002

EXPERIMENTAL

Canagliflozin 100 mg once daily and 50 mg twice daily Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.

Drug: Canagliflozin 100 mg once daily and 50 mg twice daily

Interventions

Canagliflozin 300 mg once daily and 150 mg twice daily DRUG

Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.

001

Canagliflozin 100 mg once daily and 50 mg twice daily DRUG

Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.

002

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg

You may not qualify if:

• History of or current clinically significant medical illness as determined by the Investigator
• History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
• Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin

Sponsors & Collaborators

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

Related Publications (1)

• Devineni D, Polidori D, Curtin CR, Murphy J, Wang SS, Stieltjes H, Wajs E. Pharmacokinetics and pharmacodynamics of once- and twice-daily multiple-doses of canagliflozin, a selective inhibitor of sodium glucose co-transporter 2, in healthy participants. Int J Clin Pharmacol Ther. 2015 Jun;53(6):438-46. doi: 10.5414/CP202324.

  PMID: 25907176 DERIVED

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

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 31, 2011
• Study Start: January 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 13, 2012

Record last verified: 2012-03