Phase 1 Study of Relative Bioavailability of PPI-668 Tablet and Capsule Formulations

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

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

Study Overview

• Status: Completed
• Conditions: Pharmacokinetic Assessments in Healthy Volunteers
• Intervention / Treatment: Drug: PPI-668 tablet; Drug: PPI-668 capsule

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14202
      • Buffalo Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PPI-668 capsule followed by tablet; On day 1 two 100 mg PPI-668 capsules will be administered; on day 8 one 200 mg PPI-668 tablet will be administered	Drug: PPI-668 tablet; Drug: PPI-668 capsule
EXPERIMENTAL: PPI-668 tablet followed by capsule; On day 1 one 200 mg PPI-668 tablet will be administered; on day 8 two 100 mg PPI-668 capsules will be administered	Drug: PPI-668 tablet; Drug: PPI-668 capsule

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
number of participants with adverse events	Days 1 - 8
number of participants with increases or decreases in clinical laboratory parameters such as serum albumin, sodium, and chloride levels	Days 1 - 8

Collaborators and Investigators

• Sponsor: Presidio Pharmaceuticals, Inc.
• Investigators: Study Director: Nathaniel Brown, MD, Presidio Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: November 3, 2013
• First Posted (ESTIMATE): November 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 7, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: bioavailability
• Other Study ID Numbers: PPI-668-103