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

Type 2 Diabetes Clinical Trial

— ULDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135446
• Other study ID #: MB102-088
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2010
• Last updated: October 14, 2016
• Start date: May 2010
• Est. completion date: June 2010

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• dapagliflozin
Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days
• dapagliflozin
Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days
• dapagliflozin
Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days
• dapagliflozin
Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days
• dapagliflozin
Tablets, Oral, 1 mg, once on Day 1 only, 2 days
• dapagliflozin
Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days

Locations

Country	Name	City	State
United States	Ppd Development, Lp	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect		24 hours after dosing	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		24 hours after dosing	Yes
Secondary	Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics		2 days after dosing	No

External Links

•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   MB102-088_redacted_CSR_synopsis