Drug to Drug Interaction Study With Ipragliflozin and Furosemide

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

Official Title
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A Clinical Pharmacological Study to Assess Pharmacodynamic and Pharmacokinetic Interactions Between Furosemide and Ipragliflozin in Healthy Subjects

Conditions
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Healthy Subjects, Pharmacokinetics of Ipragliflozin

Intervention / Treatment
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* Drug: Ipragliflozin
* Drug: Furosemide


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ipragliflozin<br> | Drug: Ipragliflozin<br>* Oral<br>* Other names: ASP1941;|
| Experimental: furosemide<br> | Drug: Furosemide<br>* Oral<br>|
| Experimental: ipragliflozin & furosemide<br> | Drug: Ipragliflozin<br>* Oral<br>* Other names: ASP1941;Drug: Furosemide<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of urine sodium excretion, following multiple doses of furosemide alone compared to furosemide + ipragliflozin in healthy subjects |  | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 10 days | 
| Assessment of the pharmacokinetics of furosemide when co-administered with ipragliflozin compared to furosemide alone | 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) | 10 days | 
| Assessment of the safety and tolerability of furosemide and ipragliflozin following multiple doses of furosemide alone, ipragliflozin alone, and furosemide + ipragliflozin in healthy subjects | Assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and signs and symptoms of hypoglycemia | 39 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Ipragliflozin, Furosemide, Pharmacokinetics, Pharmacodynamics