Skip to main content
OpenTrials
Completed

NCT Number: NCT01135446

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ppd Development, Lp

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

Drug

Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days

Other names: BMS-512148

Primary outcomes

  1. Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect

    Time frame: 24 hours after dosing

Secondary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 24 hours after dosing

  2. Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics

    Time frame: 2 days after dosing

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Acronym: ULDS

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 2, 2010
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.