Effects of Single Oral Dose Dapagliflozin QT Study

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo to match moxifloxacin and dapagliflozin; Drug: Dapagliflozin; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00688493

D1690C00001

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 4 patient groups, including a placebo group

20 mg single dose of dapagliflozin

Experimental group

Description:

20 mg dapagliflozin

Treatment:

Drug: Dapagliflozin

Drug: Moxifloxacin

Drug: Placebo to match moxifloxacin and dapagliflozin

Drug: Dapagliflozin

150 mg single dose of dapagliflozin2

Experimental group

Description:

150 mg dapagliflozin

Treatment:

Drug: Dapagliflozin

Drug: Moxifloxacin

Drug: Placebo to match moxifloxacin and dapagliflozin

Drug: Dapagliflozin

400 mg single dose of moxifloxacin

Active Comparator group

Description:

Moxifloxacin

Treatment:

Drug: Dapagliflozin

Drug: Moxifloxacin

Drug: Placebo to match moxifloxacin and dapagliflozin

Drug: Dapagliflozin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Dapagliflozin

Drug: Moxifloxacin

Drug: Placebo to match moxifloxacin and dapagliflozin

Drug: Dapagliflozin