A Pharmacokinetic Dose Proportionality Study of Canagliflozin in Healthy Volunteers

NCT01340677 | Completed Phase 1

• 3 other identifiers: CR01827728431754DIA10152010-023251-28
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of dose on the pharmacokinetics of canagliflozin in healthy volunteers.

Conditions

Healthy

Keywords

Canagliflozin (JNJ-28431754); Pharmacokinetic; Dose proportionality

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of canagliflozin

  For up to 12 days (4 days during treatment periods 1, 2, and 3)

Secondary Outcomes (5)

• Adverse events

  Up to approximately 42 days (includes up to 14 days between Treatment Periods 1 and 2 and up to 10 days after Day 4 of Treatment Period 3)

• Clinical laboratory tests

  Up to approximately 42 days

• Physical examinations

  Up to approximately 42 days

• 12-lead electrocardiograms (ECGs)

  Up to approximately 42 days

• Vital signs

  Up to approximately 42 days

Study Arms (1)

001

EXPERIMENTAL

Canagliflozin 100 mg Type=1 unit=mg number=100 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 300 mg Type=1 unit=mg number=300 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 50 mg Type=1 unit=mg number=50 form=tablet route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.

Drug: Canagliflozin, 50 mg; Drug: Canagliflozin, 300 mg; Drug: Canagliflozin, 100 mg

Interventions

Canagliflozin, 50 mg DRUG

Type=1, unit=mg, number=50, form=tablet, route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.

001

Canagliflozin, 300 mg DRUG

Type=1, unit=mg, number=300, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.

001

Canagliflozin, 100 mg DRUG

Type=1, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.

001

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg

You may not qualify if:

• History of or current medical illness deemed clinically significant by the Investigator (study physician)

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

Related Publications (1)

• Devineni D, Manitpisitkul P, Murphy J, Stieltjes H, Ariyawansa J, Di Prospero NA, Rothenberg P. Effect of food on the pharmacokinetics of canagliflozin, a sodium glucose co-transporter 2 inhibitor, and assessment of dose proportionality in healthy participants. Clin Pharmacol Drug Dev. 2015 Jul;4(4):279-86. doi: 10.1002/cpdd.151. Epub 2014 Dec 11.

  PMID: 27136908 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
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 22, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

BE (1)