NCT01611428CompletedPhase 1
A Single Dose, Open-label, Randomized Two-period Crossover Study in Healthy Young Subjects to Assess the Absolute Bioavailability of Ipragliflozin
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Astellas Pharma Europe B.V.
- Enrollment
- 14
- Primary Endpoint
- Assessment of the absolute bioavailability after a single oral dose of ipragliflozin
Study Overview
Brief Summary
A study to assess the absolute bioavailability of ipragliflozin in healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Ipragliflozin - oral
Experimental
open label
Intervention: Ipragliflozin (Drug)
Ipragliflozin - i.v.
Experimental
open label
Intervention: Ipragliflozin (Drug)
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(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)(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)(3 days)
Investigators
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