Absolute Bioavailability Study With Ipragliflozin

Phase 1CompletedNCT01611428

Astellas Pharma Europe B.V.14 enrolled

Overview

A study to assess the absolute bioavailability of ipragliflozin in healthy subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Bioavailability of Ipragliflozin Healthy Subjects

Interventions

IpragliflozinDRUG

Oral and Intravenous (i.v.)

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 the absolute bioavailability after a single oral dose of ipragliflozin

Time frame: 6 days

Secondary Outcomes

Evaluation of pharmacokinetics of ipragliflozin and its metabolite after a single oral dose and after an i.v. administration of ipragliflozin

AUClast (Area under the plasma concentration-time curve up to the last quantifiable sample), Cmax (Maximum plasma concentration), t1/2 (Apparent Terminal Elimination Half-life) and tmax (Time to Attain Cmax)

Time frame: 6 days

Evaluation of the safety and tolerability of a single oral dose of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)

Time frame: 3 days

Evaluation of the safety and tolerability of an i.v. administration of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs)

Time frame: 3 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.