Drug to Drug Interaction Study With Ipragliflozin and Furosemide

Phase 1

Completed

• Conditions: Healthy Subjects; Pharmacokinetics of Ipragliflozin
• Interventions: Drug: Ipragliflozin; Drug: Furosemide

• Registration Number: NCT01611415
• Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary

A study to investigate if there are any pharmacodynamic and pharmacokinetic interactions between furosemide and ipragliflozin (ASP1941) in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-10
• Study Completion: 2011-10
• 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: 24

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 & furosemide	Furosemide	-
ipragliflozin	Ipragliflozin	-
furosemide	Furosemide	-
ipragliflozin & furosemide	Ipragliflozin	-

Primary Outcome Measures

Name	Time	Method
Assessment of urine sodium excretion, following multiple doses of furosemide alone compared to furosemide + ipragliflozin in healthy subjects	6 days

Secondary Outcome Measures

Name	Time	Method
Assessment of urine sodium excretion, following multiple doses of ipragliflozin alone compared to furosemide + ipragliflozin in healthy subjects	6 days
Assessment of pharmacodynamic parameters (i.e. calcium, chloride, potassium, phosphate and magnesium in blood and urine) following multiple doses of furosemide alone, ipragliflozin alone, and furosemide + ipragliflozin in healthy subjects	9 days
Assessment of the pharmacokinetics of ipragliflozin when co-administered with furosemide compared to ipragliflozin alone	10 days	AUCtau (AUC during the time interval between consecutive dosing), Cmax (Maximum plasma concentration), t1/2 (Apparent Terminal Elimination Half-life) and tmax (Time to Attain Cmax)
Assessment of the pharmacokinetics of furosemide when co-administered with ipragliflozin compared to furosemide alone	10 days	AUCtau (AUC during the time interval between consecutive dosing), Cmax (Maximum plasma concentration), t1/2 (Apparent Terminal Elimination Half-life) and tmax (Time to Attain Cmax)
Assessment of the safety and tolerability of furosemide and ipragliflozin following multiple doses of furosemide alone, ipragliflozin alone, and furosemide + ipragliflozin in healthy subjects	39 days	Assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and signs and symptoms of hypoglycemia