Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: dapagliflozin

• Registration Number: NCT01135446
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-27
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Healthy men and women
• WOCBP who are using acceptable method of contraception
• Women who are not nursing

Exclusion Criteria

• History of GI disease
• Any GI surgery that could impact study drug absorption
• Glucosuria at screening or Day -2
• Abnormal liver function tests (ALT, AST or total bilirubin > 10% above ULN)
• History of current or recurrent UTI
• History of Diabetes Mellitus
• History of chronic or recurrent vulvovaginal mycotic infections
• Estimated creatinine clearance (ClCr) < 80 mL/min using Cockroft-Gault formula
• History of allergy to SGLT2 inhibitors or related compounds

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dapagliflozin (0.001 mg)	dapagliflozin	Cohort 1
dapagliflozin (0.01 mg)	dapagliflozin	Cohort 2
dapagliflozin (0.1 mg)	dapagliflozin	Cohort 3
dapagliflozin (0.3 mg)	dapagliflozin	Cohort 4
dapagliflozin (1 mg)	dapagliflozin	Cohort 5
dapagliflozin (2.5 mg)	dapagliflozin	Cohort 6

Primary Outcome Measures

Name	Time	Method
Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect	24 hours after dosing

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	24 hours after dosing
Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics	2 days after dosing

Trial Locations

Locations (1)

Ppd Development, Lp; 🇺🇸 Austin, Texas, United States