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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT02307461

Run by

SecuraBio

People needed

103

Starts

2014-11-01

Expected to finish

2015-09-01

Last updated by the study team

2021-03-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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