Phase 1 Study in Healthy Subjects to Evaluate the Effect of IPI-145 on the Pharmacokinetics of Midazolam

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: IPI-145
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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/m2. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: IPI-145|25 mg BID Oral Capsule|
|Drug: Midazolam|2 mg midazolam syrup|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters (AUC) of midazolam and 1-hydroxy-midazolam |  | Over 24 hours | 
| Pharmacokinetic parameters (Cmax) of midazolam and 1-hydroxy-midazolam |  | Over 24 hours | 
| Pharmacokinetic parameters (t1/2) of midazolam and 1-hydroxy-midazolam |  | Over 24 hours | 
| Plasma concentrations of midazolam and 1-hydroxy-midazolam |  | Over 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events following of administration midazolam, IPI-145 and the combination | Safety Findings | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DDI, Phase 1, Healthy subjects, CYP3A