IPI-145 ADME and Absolute Bioavailability Study

Secura Bio

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: IPI-145

Study type

Interventional

Funder types

Industry

Identifiers

NCT01836861

IPI-145-05

2012-005425-75 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment

6 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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)