Clinical trial NCT01979484: Phase 1 Study of Relative Bioavailability of PPI-668 Tablet and Capsule Formulations
Official title: A Phase 1, Open-Label, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a New Tablet Formulation Versus the Current Capsule Formulation of PPI-668 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetic Assessments in Healthy Volunteers
Keywords: bioavailability
Lead sponsor: Presidio Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet.


Eligibility criteria: Inclusion Criteria:

1. Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
2. Must be between 18 and 55 years of age, inclusive.
3. Must be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug.
4. Must have a calculated body mass index (BMI) of 18.0 to 29.9 kg/m2.
5. Must be HIV-1 antibody negative.
6. Must be hepatitis B (HBV) surface antigen negative.
7. Must be hepatitis C (HCV) antibody negative.

Exclusion Criteria:

1. Pregnant or lactating subjects.
2. 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.
3. Have participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing.
4. Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
5. Have poor venous access and unable to donate blood.
6. Have donated blood within 56 days of study dosing.
7. Have donated plasma within 7 days of study dosing.
8. 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.

Primary outcomes:
measure: PPI-668 area under the curve from time zero to infinity (AUC 0-inf)
timeFrame: Days 1 - 8
measure: PPI-668 maximum observed plasma concentration (Cmax)
timeFrame: Days 1 - 8
measure: PPI-668 area under the curve from time zero to the last quantifiable concentration (AUC 0-t)
timeFrame: Days 1 - 8
Secondary outcomes:
measure: number of participants with adverse events
timeFrame: Days 1 - 8
measure: number of participants with increases or decreases in clinical laboratory parameters such as serum albumin, sodium, and chloride levels
timeFrame: Days 1 - 8
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Buffalo Clinical Research Center
state: New York
Study officials:
affiliation: Presidio Pharmaceuticals
name: Nathaniel Brown, MD
role: STUDY_DIRECTOR
References: