NCT01925911CompletedPhase 1
A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of IPI-145 on Single-Dose Pharmacokinetics of Midazolam (a CYP3A Substrate) in Healthy Subjects
SecuraBio2 sites in 1 country14 target enrollmentStarted: August 1, 2013Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Plasma concentrations of midazolam and 1-hydroxy-midazolam
Study Overview
Brief Summary
To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A (CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with midazolam in healthy subjects.
Detailed Description
- In Treatment Period 1, subjects will receive a single 2 mg oral dose of midazolam.
- In Treatment Period 2, on Days 2-6, the same subjects will receive twice daily (BID) oral doses of 25 mg IPI-145; on Day 6, subjects will receive the morning dose of 25 mg IPI-145 concomitantly administered with 2 mg of midazolam.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy men or women of non-childbearing potential between 18-50 years of age
- •Body Mass Index (BMI): 18.0 - 32.0 kg/m
- •In good health, determined by no clinically significant findings from clinical evaluations
- •Provided written informed consent prior to any study specific procedures
Exclusion Criteria
- •Women of childbearing potential
- •Evidence of clinically significant medical conditions
- •History of gastrointestinal disease or surgery that may affect drug absorption
- •Positive or indeterminate tuberculosis-spot test at screening
- •Any active infection at the time of screening or admission
- •Subjects with acute narrow-angle glaucoma
Outcomes
Primary Outcomes
Plasma concentrations of midazolam and 1-hydroxy-midazolam
Time Frame: Over 24 hours
Pharmacokinetic parameters (Cmax) of midazolam and 1-hydroxy-midazolam
Time Frame: Over 24 hours
Pharmacokinetic parameters (t1/2) of midazolam and 1-hydroxy-midazolam
Time Frame: Over 24 hours
Pharmacokinetic parameters (AUC) of midazolam and 1-hydroxy-midazolam
Time Frame: Over 24 hours
Secondary Outcomes
- Incidence of adverse events following of administration midazolam, IPI-145 and the combination(2 weeks)
Investigators
Study Sites (2)
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