Status:
COMPLETED
Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145
Lead Sponsor:
SecuraBio
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145
Detailed Description
This Phase 1, randomized, open-label study of IPI-145 will be conducted in 2 parts. Part 1 will be conducted in 2 cohorts. Cohort 1 will consist of 32 healthy subjects, and Cohort 2 will consist of 5...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT02307461
Start Date
November 1 2014
End Date
September 1 2015
Last Update
March 17 2021
Active Locations (1)
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1
Lenexa, Kansas, United States, 66219