NCT01395927

Brief Summary

The purpose of this study is to evaluate blood levels of canagliflozin in healthy volunteers before and after the administration of multiple-doses of rifampin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2011

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

May 6, 2013

Status Verified

May 1, 2013

Enrollment Period

1 month

First QC Date

July 14, 2011

Last Update Submit

May 3, 2013

Conditions

Healthy

Keywords

CanagliflozinRifampinPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of canagliflozin

    Day 1 up to Day 13

Secondary Outcomes (2)

  • Plasma concentrations of Rifampin

    Day 9 up to Day 13

  • Adverse events reported

    For approximately 13 days

Study Arms (1)

001

EXPERIMENTAL

Canagliflozin Type=1 unit=mg number=300 form=tablet. Single dose of one 300-mg tablet on Day 1 and Day 10,Rifampin Type=2 unit=mg number=300 Form=capsule route=oral use. Two 300-mg capsules once daily on days Days 4 through 12.

Drug: RifampinDrug: Canagliflozin

Interventions

RifampinDRUG

Type=2, unit=mg, number=300, Form=capsule, route=oral use. Two 300-mg capsules once daily on days Days 4 through 12.

001
CanagliflozinDRUG

Type=1, unit=mg, number=300, form=tablet. Single dose of one 300-mg tablet on Day 1 and Day 10

001

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive)

You may not qualify if:

  • History of or current medical illness deemed clinically significant by the Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

RifampinCanagliflozin

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic CompoundsThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingGlucosidesGlycosidesCarbohydrates

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
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 18, 2011

Study Start

July 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 6, 2013

Record last verified: 2013-05

Locations

US(1)