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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01135446

MB102-088

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

35 participants in 6 patient groups

dapagliflozin (0.001 mg)

Experimental group

Description:

Cohort 1

Treatment:

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

dapagliflozin (0.01 mg)

Experimental group

Description:

Cohort 2

Treatment:

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

dapagliflozin (0.1 mg)

Experimental group

Description:

Cohort 3

Treatment:

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

dapagliflozin (0.3 mg)

Experimental group

Description:

Cohort 4

Treatment:

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

dapagliflozin (1 mg)

Experimental group

Description:

Cohort 5

Treatment:

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

dapagliflozin (2.5 mg)

Experimental group

Description:

Cohort 6

Treatment:

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin

Drug: dapagliflozin