A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of Digoxin in Healthy Volunteers.

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01714206
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Digoxin 0.5 mg — DRUG
    Two 0.25 mg tablets (0.5 mg total dose) taken orally (by mouth) on Day 1.
  • Digoxin 0.25 mg — DRUG
    One 0.25 mg tablet taken orally on Days 2 through 7.
  • Canagliflozin (JNJ-28431754) — DRUG
    One 300 mg tablet taken orally on Days 1 through 7.

Study Details

The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754) affect the pharmacokinetics (ie, how the body affects the drug) of multiple doses of digoxin. The safety and tolerability of canagliflozin will also be assessed in healthy volunteers.

Key Dates

Start date
Jun 30, 2009
Status verified
Nov 2012
Primary completion
Sep 30, 2009
Completion
Sep 30, 2009

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment A
    Each volunteer will receive digoxin once daily on Days 1 through 7.
  • Experimental: Treatment B
    Each volunteer will receive digoxin once daily on Days 1 through 7 in combination with canagliflozin (JNJ-28431754) once daily on Days 1 through 7.

Primary Outcome Measure

Plasma concentration of digoxin [ Time Frame: Days 5 through 7 ]

Related Studies