Pharmacokinetic Assessments in Healthy Volunteers
Conditions
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.
Interventions
DRUGPPI-668 tablet
DRUGPPI-668 capsule
Sponsors
Presidio Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PPI-668 area under the curve from time zero to infinity (AUC 0-inf) | days 1-8 |
| PPI-668 maximum observed plasma concentration (Cmax) | Days 1-8 |
| PPI-668 area under the curve from time zero to the last quantifiable concentration (AUC 0-t) | Days 1-8 |
Secondary
| Measure | Time frame |
|---|---|
| assessments of adverse events | days 1-8 |
| assessments of composite of clinical laboratory parameters | days 1-8 |
Countries
United States
Outcome results
None listed