PK Study of Dapagliflozin in Pediatric Subjects With T2DM

This study is currently recruiting participants.

Verified October 2012 by Bristol-Myers Squibb

Sponsor:

Collaborators:

AstraZeneca

Parexel

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01525238

First received: January 31, 2012

Last updated: October 5, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 31, 2012

Last Updated Date

October 5, 2012

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum observed plasma concentration (Cmax) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Time of maximum observed plasma concentration (Tmax) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Dapagliflozin derived from plasma concentration versus time [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Dapagliflozin derived from plasma concentration versus time [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Plasma half-life (T-HALF) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Percent urinary recovery (%UR) of Dapagliflozin derived from urinary excretion data [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Renal clearance from time zero to 24 hours post-dose [CLR(0-24)] of Dapagliflozin derived from urinary excretion data [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Apparent clearance after extravascular administration (CL/F) of Dapagliflozin derived from urinary excretion data [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Apparent volume of distribution at terminal phase after extravascular administration (Vz/F) of Dapagliflozin derived from urinary excretion data [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01525238 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety: based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs) and clinical laboratory tests [ Time Frame: 48 hours post dosing ] [ Designated as safety issue: Yes ]
Maximum observed plasma concentration (Cmax) of Dapagliflozin 3-O-Glucuronide [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Time of maximum observed plasma concentration (Tmax) of Dapagliflozin 3-O-Glucuronide [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Plasma half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Percent urinary recovery (%UR) of Dapagliflozin 3-O-Glucuronide [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Renal clearance from time zero to 24 hours post-dose [CLR(0-24)] of Dapagliflozin 3-O-Glucuronide [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Apparent clearance after extravascular administration (CL/F) of Dapagliflozin 3-O-Glucuronide [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Apparent volume of distribution at terminal phase after extravascular administration (Vz/F) of Dapagliflozin 3-O-Glucuronide [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Fasting plasma glucose concentration [ Time Frame: At pre-dose on Day 1 and Day 2 after an 8-hr fasting ] [ Designated as safety issue: No ]
Urinary glucose amounts [ Time Frame: First 24 h after Dapagliflozin administration ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

PK Study of Dapagliflozin in Pediatric Subjects With T2DM

Official Title ^ICMJE

A Randomized, Multi-Center, Parallel Group, Single-Dose, Pharmacokinetics and Pharmacodynamics Study of Dapagliflozin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)

Detailed Description

Primary purpose: The primary purpose is to assess the pharmacokinetics of a single dose of Dapagliflozin in the range of 2.5 to 10 mg in pediatric subjects aged 10 to 17 years with T2DM

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: Dapagliflozin
Tablet, Oral, 2.5 mg, Single-dose
Drug: Dapagliflozin
Tablet, Oral, 5 mg, Single-dose
Drug: Dapagliflozin
Tablet, Oral, 10 mg, Single-dose

Study Arm (s)

Experimental: Dapagliflozin 2.5 mg
Intervention: Drug: Dapagliflozin
Experimental: Dapagliflozin 5 mg
Intervention: Drug: Dapagliflozin
Experimental: Dapagliflozin 10 mg
Intervention: Drug: Dapagliflozin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2012

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinical diagnosis of T2DM
Male and female subjects ages 10-17
Glycosylated Hemoglobin A1c (HbA1c) 6.5 to 10%

Exclusion Criteria:

Fasting plasma glucose (FPG) > 240 mg/dL at screening
Abnormal renal function
Active liver disease and/or significant abnormal liver function

Gender

Both

Ages

10 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01525238

Other Study ID Numbers ^ICMJE

MB102-091

Has Data Monitoring Committee

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

AstraZeneca
Parexel

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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