DDI: Phase 1 Study in Healthy Subjects to Evaluate the Effect of Rifampin on the Pharmacokinetics of IPI-145
Study Details
Study Description
Brief Summary
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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
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In Treatment Period 1, subjects will receive a single 25 mg oral dose of IPI-145
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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
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- Incidence of adverse events following administration of IPI-145, rifampin, and the combination. [2 weeks]
Safety Findings
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy men or women of non-childbearing potential between 18-50 years of age
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Body Mass Index (BMI): 18.0 - 32.0 kg/m2
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In good health, determined by no clinically significant findings from clinical evaluations
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Provided written informed consent prior to any study specific procedures
Exclusion Criteria:
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Women of childbearing potential
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Evidence of clinically significant medical conditions
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History of gastrointestinal disease or surgery that may affect drug absorption
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Positive or indeterminate Tuberculosis -spot test at screening
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Any active infection at the time of screening or admission
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | PRA International, Inc | Lenexa | Kansas | United States | 66219 |
Sponsors and Collaborators
- SecuraBio
Investigators
- Study Chair: Hagop Youssoufian, MD, Verastem, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IPI-145-11