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

January 20, 2015 updated by: Presidio Pharmaceuticals, Inc.

A Phase 1, Open-Label, 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, T003.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PPI-668 tablet followed by capsule
On day 1, one 200 mg PPI-668 tablet will be administered. On day 6, two 100 mg PI-668 capsules will be administered.
Drug: PPI-668 tablet
Drug: PPI-668 capsule
EXPERIMENTAL: PPI-668 capsule followed by tablet
On day 1, two 100 mg PI-668 capsules will be administered. On day 6, one 200 mg PPI-668 tablet 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)
Time Frame: days 1-8
days 1-8
PPI-668 maximum observed plasma concentration (Cmax)
Time Frame: Days 1-8
Days 1-8
PPI-668 area under the curve from time zero to the last quantifiable concentration (AUC 0-t)
Time Frame: Days 1-8
Days 1-8

Secondary Outcome Measures

Outcome Measure
Time Frame
assessments of adverse events
Time Frame: days 1-8
days 1-8
assessments of composite of clinical laboratory parameters
Time Frame: days 1-8
days 1-8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Presidio Pharmaceuticals, Inc.

Investigators

  • Study Director: Nathaniel Brown, MD, Presidio Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (ESTIMATE)

October 7, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 22, 2015

Last Update Submitted That Met QC Criteria

January 20, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • PPI-668-104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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