Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145

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

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.; SecuraBio

Criteria

Inclusion Criteria:

• Men or women of non-child bearing potential between 18-50 years of age

• Body Mass Index (BMI): 18.0 - 32.0 kg/m2.

• Healthy subjects: 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

• Healthy subjects: positive screening test for hepatitis B surface antigen, hepatitis C antibody, or HIV-1/HIV-2 antibodies

• ECG at screening showing QTcF ≥ 450 msec

• Evidence of clinically significant medical conditions

• History of gastrointestinal disease or surgery that may affect drug absorption

• Positive T-Spot (tuberculosis)TB test at screening

• Any active infection at the time of screening or admission