PK Study of Dapagliflozin in Pediatric Subjects With T2DM

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01525238
First received: January 31, 2012
Last updated: September 24, 2014
Last verified: September 2014

January 31, 2012
September 24, 2014
July 2012
December 2013   (final data collection date for primary outcome measure)
  • Maximum observed plasma concentration (Cmax) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: 11 time points up to Day 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: 11 time points up to Day 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: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Plasma half-life (T-HALF) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Apparent clearance after extravascular administration (CL/F) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Apparent volume of distribution at terminal phase after extravascular administration (Vz/F) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT01525238 on ClinicalTrials.gov Archive Site
  • Safety: based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs) and clinical laboratory tests [ Time Frame: Up to Day 3 ] [ Designated as safety issue: Yes ]
  • Maximum observed plasma concentration (Cmax) of Dapagliflozin 3-O-Glucuronide [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) of Dapagliflozin 3-O-Glucuronide [ Time Frame: 11 time points up to Day 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: 11 time points up to Day 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: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Plasma half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide [ Time Frame: 11 time points up to Day 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 ]
  • 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 ]
Not Provided
Not Provided
 
PK Study of Dapagliflozin in Pediatric Subjects With T2DM
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

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

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Type 2 Diabetes Mellitus
  • 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
  • Experimental: Dapagliflozin 2.5 mg
    Intervention: Drug: Dapagliflozin
  • Experimental: Dapagliflozin 5 mg
    Intervention: Drug: Dapagliflozin
  • Experimental: Dapagliflozin 10 mg
    Intervention: Drug: Dapagliflozin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
February 2015
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of T2DM
  • Male and female subjects ages 10-17
  • Glycosylated Hemoglobin A1c (HbA1c) >6 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
Both
10 Years to 17 Years
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
United States,   Mexico
 
NCT01525238
MB102-091, 2011-005225-40
No
Bristol-Myers Squibb
Bristol-Myers Squibb
AstraZeneca
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2014

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