Status:
COMPLETED
Phase 1 Study of Relative Bioavailability of PPI-668 New Tablet Versus Capsule Formulations
Lead Sponsor:
Presidio Pharmaceuticals, Inc.
Conditions:
Pharmacokinetic Assessments in Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet, T003.
Eligibility Criteria
Inclusion
- Have the ability to understand and sign a written informed consent form
- nonsmoker
- body mass index (BMI) of 18.0 to 29.9 kg/m2 (inclusive)
- HIV-1 antibody negative.
- hepatitis B (HBV) surface antigen negative.
- hepatitis C (HCV) antibody negative.
Exclusion
- Pregnant or lactating subjects.
- Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematologic, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central or peripheral nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), or immunodeficiency disorders, active infection, or malignancy that is clinically significant or requiring treatment.
- Have participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing.
- Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
- Have poor venous access and unable to donate blood.
- Have donated blood within 56 days of study dosing.
- Have donated plasma within 7 days of study dosing.
- Have taken any prescription medications or over-the-counter medications including herbal products within 28 days of commencing study drug dosing with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or contraceptive medications.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02258321
Start Date
October 1 2014
End Date
December 1 2014
Last Update
January 22 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Buffalo Clinical Research Center
Buffalo, New York, United States, 14202