A Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01428284
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
15 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Canagliflozin/Probenecid — DRUG
    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).

Study Details

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.

Key Dates

Start date
Aug 31, 2011
Status verified
Feb 2012
Primary completion
Oct 31, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 001
    Canagliflozin/Probenecid

Primary Outcome Measure

Plasma concentrations of Canagliflozin (including canagliflozin metabolites) [ Time Frame: Up to Day 18 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-Overland ParkKansas--

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