Drug to Drug Interaction Study With Ipragliflozin and Furosemide

Astellas Pharma Europe B.V.24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Subjects Pharmacokinetics of Ipragliflozin

Interventions

IpragliflozinDRUG

Oral

FurosemideDRUG

Oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Unnamed facility

Leeds, United Kingdom

Outcomes

Primary Outcomes

Assessment of urine sodium excretion, following multiple doses of furosemide alone compared to furosemide + ipragliflozin in healthy subjects

Time frame: 6 days

Secondary Outcomes

Assessment of urine sodium excretion, following multiple doses of ipragliflozin alone compared to furosemide + ipragliflozin in healthy subjects

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 39 days

Data from ClinicalTrials.gov

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