Status:
COMPLETED
IPI-145 ADME and Absolute Bioavailability Study
Lead Sponsor:
SecuraBio
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01836861
Start Date
March 1 2013
End Date
May 1 2013
Last Update
March 17 2021
Active Locations (1)
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1
Pharmaceuticals Research Association (PRA)
Zuidlaren, Netherlands