Effects of Single Oral Dose Dapagliflozin QT Study

Condition(s) targeted: Healthy

Intervention: Dapagliflozin (Drug); Dapagliflozin (Drug); Moxifloxacin (Drug); Placebo to match moxifloxacin and dapagliflozin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Glenn Carlson, MD, Study Director, Affiliation: AstraZeneca
Ronald Goldwater, MD, Principal Investigator, Affiliation: Parexel International

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

Official title: A Double-Blind, Randomized, Four-Period Crossover Study to Assess the Effects of Single Oral Dose Dapagliflozin Administration on QTc Interval Compared to Placebo, Using AVELOX™ (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers Age 18 to 45 Years

Study design: Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study

Primary outcome: Electronic measures of heart beats

Secondary outcome:

Blood levels of dapagliflozin following single 20 mg and 150 mg doses in healthy volunteers

Safety and tolerability of dapagliflozin

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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

Research Site, Baltimore, Maryland, United States

Starting date: July 2007
Ending date: May 2008
Last updated: June 2, 2008