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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.; SecuraBio
• Treatments: Midazolam

Criteria

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