Absolute Bioavailability Study With Ipragliflozin

Phase 1

Completed

• Conditions: Bioavailability of Ipragliflozin; Healthy Subjects
• Interventions: Drug: Ipragliflozin

• Registration Number: NCT01611428
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-05
• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-05-31
• Last Update Submitted: 2012-05-31
• Study First Posted: 2012-06-05
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ipragliflozin - oral	Ipragliflozin	open label
Ipragliflozin - i.v.	Ipragliflozin	open label

Primary Outcome Measures

Name	Time	Method
Assessment of the absolute bioavailability after a single oral dose of ipragliflozin	6 days

Secondary Outcome Measures

Name	Time	Method
Evaluation of pharmacokinetics of ipragliflozin and its metabolite after a single oral dose and after an i.v. administration of ipragliflozin	6 days	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)
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
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