Absolute Bioavailability Study With Ipragliflozin

Healthy Subjects Clinical Trial

Official title:

A Single Dose, Open-label, Randomized Two-period Crossover Study in Healthy Young Subjects to Assess the Absolute Bioavailability of Ipragliflozin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611428
• Other study ID #: 1941-CL-0057
• Secondary ID: 2010-023813-77
• Status: Completed
• Phase: Phase 1
• First received: May 31, 2012
• Last updated: May 31, 2012
• Start date: June 2011
• Est. completion date: July 2011

Study information

• Verified date: May 2012
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

A study to assess the absolute bioavailability of ipragliflozin in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) more than or equal to 18.5 and less than 30.0 kg/m2

Exclusion Criteria:

• Any of the liver function tests above the upper limit of normal.

• Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows:

Pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)

• A QTc interval of >430 ms (males) or > 450 ms (females) consistently after duplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bioavailability of Ipragliflozin
• Healthy Subjects

Intervention

Drug:
• Ipragliflozin
Oral and Intravenous (i.v.)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the absolute bioavailability after a single oral dose of ipragliflozin		6 days	No
Secondary	Evaluation of pharmacokinetics of ipragliflozin and its metabolite after a single oral dose and after an i.v. administration of ipragliflozin	AUClast (Area under the plasma concentration-time curve up to the last quantifiable sample), Cmax (Maximum plasma concentration), t1/2 (Apparent Terminal Elimination Half-life) and tmax (Time to Attain Cmax)	6 days	No
Secondary	Evaluation of the safety and tolerability of a single oral dose of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)		3 days	No
Secondary	Evaluation of the safety and tolerability of an i.v. administration of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)		3 days	No