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

Study Overview
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Brief Summary
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To evaluate the effect of rifampin, a cytochrome P450 3A (CYP3A) inducer, on the pharmacokinetics (PK) of IPI-145; to assess the safety and tolerability of IPI-145 when administered with rifampin in healthy subjects

Detailed Description
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In Treatment Period 1, subjects will receive a single 25 mg oral dose of IPI-145 In Treatment Period 2, on Days 3-9, the same subjects will receive once daily (QD) oral doses of 600 mg rifampin; on Day 9, subjects will receive a single oral dose of 25 mg IPI-145 concomitantly administered with 600 mg of rifampin

Official Title
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A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of Rifampin (a CYP3A Inducer) on the Pharmacokinetics of IPI-145 in Healthy Subjects

Conditions
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Healthy

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


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 Consumption of any nutrients known to modulate cytochrome P450 enzyme activity within 14 days prior to administration of study drug, during the study, and until after discharge

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 oral capsule|
|Drug: Rifampin|2x 300 mg oral capsule|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters (AUC) of IPI-145 and its metabolite, IPI-656 |  | Over 48 hours | 
| Pharmacokinetic parameters (Cmax) of IPI-145 and its metabolite, IPI-656 |  | Over 48 hours | 
| Pharmacokinetic parameters (t1/2) of IPI-145 and its metabolite, IPI-656 |  | Over 48 hours | 
| Plasma concentrations of IPI-145 and its metabolite, IPI-656 |  | Over 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events following administration of IPI-145, rifampin, 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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Phase 1, Healthy subjects, DDI, CYP3A