Drug to Drug Interaction Study With Ipragliflozin and Furosemide

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611415
• Other study ID #: 1941-CL-0054
• Secondary ID: 2010-024071-98
• Status: Completed
• Phase: Phase 1
• First received: May 31, 2012
• Last updated: May 31, 2012
• Start date: July 2011
• Est. completion date: October 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 investigate if there are any pharmacodynamic and pharmacokinetic interactions between furosemide and ipragliflozin (ASP1941) in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2011
• Est. primary completion date: October 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: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects
• Pharmacokinetics of Ipragliflozin

Intervention

Drug:
• Ipragliflozin
Oral
• Furosemide
Oral

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 urine sodium excretion, following multiple doses of furosemide alone compared to furosemide + ipragliflozin in healthy subjects		6 days	No
Secondary	Assessment of urine sodium excretion, following multiple doses of ipragliflozin alone compared to furosemide + ipragliflozin in healthy subjects		6 days	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No