Effects of Single Oral Dose Dapagliflozin QT Study

Conditions

• Healthy

Eligibility Criteria

Sex

MALE

Age

18 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• Dapagliflozin — DRUG
  3 x 50 mg tablets, single oral dose
• Dapagliflozin — DRUG
  2 x 10 mg capsules, single oral dose
• Moxifloxacin — DRUG
  Overencapsulated 400 mg capsule, single oral dose
• Placebo to match moxifloxacin and dapagliflozin — DRUG
  Overencapsulated 400 mg capsule, single oral dose

Study Details

The main purpose of this study is to examine the effect of dapagliflozin on electronic measures of heart beats in healthy males

Key Dates

Start date

Jul 31, 2007

Status verified

Mar 2012

Completion

Apr 30, 2008

Study Design

Enrollment

36 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: 20 mg single dose of dapagliflozin
  20 mg dapagliflozin
• Experimental: 150 mg single dose of dapagliflozin2
  150 mg dapagliflozin
• Active Comparator: 400 mg single dose of moxifloxacin
  Moxifloxacin
• Placebo Comparator: Placebo
  Placebo

Primary Outcome Measure

Electronic measures of heart beats [ Time Frame: ECGs (electronic measures of the heart) are taken at scheduled times during the 3 days after receiving each dose of study medication ]

Locations (1)

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