Drug to Drug Interaction Study With Ipragliflozin and Furosemide

NCT01611415 | Completed Phase 1

• 2 other identifiers: 1941-CL-00542010-024071-98
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects; Pharmacokinetics of Ipragliflozin

Keywords

Phase 1; Ipragliflozin; Furosemide; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

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

  6 days

Secondary Outcomes (5)

• 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

• Assessment of the pharmacokinetics of furosemide when co-administered with ipragliflozin compared to furosemide alone

  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

  39 days

Study Arms (3)

ipragliflozin

EXPERIMENTAL

Drug: Ipragliflozin

furosemide

EXPERIMENTAL

Drug: Furosemide

ipragliflozin & furosemide

EXPERIMENTAL

Drug: Ipragliflozin; Drug: Furosemide

Interventions

Ipragliflozin DRUG

Oral

Also known as: ASP1941

ipragliflozin; ipragliflozin & furosemide

Furosemide DRUG

Oral

furosemide; ipragliflozin & furosemide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) more than or equal to 18.5 and less than 30.0 kg/m2

You may not qualify if:

• 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)

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (1)

Unknown Facility

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

ipragliflozin; Furosemide

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Clinical Study Manager

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 5, 2012
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 5, 2012

Record last verified: 2012-05

Locations

GB (1)