IPI-145 ADME and Absolute Bioavailability Study

A Phase 1, Open-Label Study of the Absorption, Distribution, Metabolism and Excretion of 14C-Labeled IPI-145 and the Absolute Bioavailability of IPI-145 in Healthy Subjects

This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects.

In Period 1, subjects will receive a single oral dose of 25 mg IPI-145, followed by a 15-minute IV infusion of approximately 2.8 μg 14C-IPI-145 containing 14.8 kBq of radioactivity.

In Period 2, the same subjects will receive a single dose of 25 mg 14C-IPI-145 as an oral suspension, containing approximately 3.15 MBq of radioactivity.

There will be a washout period of at least 14 days between Period 1 and Period 2.

Inclusion Criteria:

• Males, between 18 and 45 years of age, inclusive Body Mass Index (BMI) : 18.0-30.0 kg/m2
• In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs
• Provision of signed and dated, written informed consent prior to any study specific procedures

Exclusion Criteria:

• Evidence of clinically significant medical conditions
• History of gastrointestinal surgery that may affect drug absorption
• Positive or indeterminate QuantiFERON-TB Gold test at screening
• Any active infection at the time of screening or admission
• Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year before screening
• Irregular defecation pattern (less than once per 2 days)