Effects of Single Oral Dose Dapagliflozin QT Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Dapagliflozin; Drug: Moxifloxacin; Drug: Placebo to match moxifloxacin and dapagliflozin

• Registration Number: NCT00688493
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study Completion: 2008-04
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-20
• Last Update Posted: 2012-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• Healthy males age 18 to 45 years of age, who are not currently taking any medications
• Normal screening results including a physical examination, laboratory tests, heart rate, blood pressure, and ECG (electronic measure of the heart)

Exclusion Criteria

• No personal or family history of significant heart problems
• No use of over the counter medications within 7 days of the study
• No use of prescription medicaiton within 1 month of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
20 mg single dose of dapagliflozin	Dapagliflozin	20 mg dapagliflozin
20 mg single dose of dapagliflozin	Moxifloxacin	20 mg dapagliflozin
20 mg single dose of dapagliflozin	Placebo to match moxifloxacin and dapagliflozin	20 mg dapagliflozin
150 mg single dose of dapagliflozin2	Moxifloxacin	150 mg dapagliflozin
400 mg single dose of moxifloxacin	Dapagliflozin	Moxifloxacin
150 mg single dose of dapagliflozin2	Placebo to match moxifloxacin and dapagliflozin	150 mg dapagliflozin
400 mg single dose of moxifloxacin	Moxifloxacin	Moxifloxacin
400 mg single dose of moxifloxacin	Placebo to match moxifloxacin and dapagliflozin	Moxifloxacin
Placebo	Dapagliflozin	Placebo
Placebo	Placebo to match moxifloxacin and dapagliflozin	Placebo
150 mg single dose of dapagliflozin2	Dapagliflozin	150 mg dapagliflozin
Placebo	Moxifloxacin	Placebo

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood levels of dapagliflozin following single 20 mg and 150 mg doses in healthy volunteers	At scheduled times during the 3 day periods following dosing during each of the 4 study periods
Safety and tolerability of dapagliflozin	Screening through completion of the study

Trial Locations

Locations (1)

Research Site; 🇺🇸 Baltimore, Maryland, United States