Effects of Single Oral Dose Dapagliflozin QT Study

AstraZeneca36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

DapagliflozinDRUG

3 x 50 mg tablets, single oral dose

DapagliflozinDRUG

2 x 10 mg capsules, single oral dose

MoxifloxacinDRUG

Overencapsulated 400 mg capsule, single oral dose

Placebo to match moxifloxacin and dapagliflozin

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Time frame: At scheduled times during the 3 day periods following dosing during each of the 4 study periods

Safety and tolerability of dapagliflozin

Time frame: Screening through completion of the study

Data from ClinicalTrials.gov

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