NCT01428284

Brief Summary

The purpose of this study is to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. Safety and tolerability will also be assessed.

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 Aug 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

2 months

First QC Date

September 1, 2011

Last Update Submit

February 16, 2012

Conditions

Healthy

Keywords

Healthy VolunteersCanagliflozin (JNJ-28431754)PharmacokineticProbenecid

Outcome Measures

Primary Outcomes (2)

  • Plasma concentrations of Canagliflozin (including canagliflozin metabolites)

    Up to Day 18

  • Plasma concentrations of probenecid

    Up to Day 17

Secondary Outcomes (3)

  • Adverse Events

    Up to 10 days following Day 18

  • Clinical Laboratory Tests

    Up to 10 days following Day 18

  • Vital Signs

    Up to 10 days following Day 18

Study Arms (1)

001

EXPERIMENTAL

Canagliflozin/Probenecid

Drug: Canagliflozin/Probenecid

Interventions

Canagliflozin/ProbenecidDRUG

Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use. Probenicid: Type = 1, unit = mg, number = 500, form = tablet, route = oral use. One 300-mg canagliflozin tablet taken orally once daily on Days 1 to 14 (administration of canagliflozin alone) and on Days 15 to 17 (administration of canagliflozin + twice-daily administration of probenecid).

001

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

CanagliflozinProbenecid

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydratesSulfonamidesAmidesSulfones

Study Officials

  • Johnson & Johnson Pharmaceutical Research and 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
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 2, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations

US(1)