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OpenTrials
Completed

NCT Number: NCT02258321

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

This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet, T003.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Buffalo Clinical Research Center

Buffalo, New York, 14202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PPI-668 tablet

Drug

PPI-668 capsule

Drug

Primary outcomes

  1. PPI-668 area under the curve from time zero to infinity (AUC 0-inf)

    Time frame: days 1-8

  2. PPI-668 maximum observed plasma concentration (Cmax)

    Time frame: Days 1-8

  3. PPI-668 area under the curve from time zero to the last quantifiable concentration (AUC 0-t)

    Time frame: Days 1-8

Secondary outcomes

  1. assessments of adverse events

    Time frame: days 1-8

  2. assessments of composite of clinical laboratory parameters

    Time frame: days 1-8

Sponsors and collaborators

Lead sponsor

Presidio Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 7, 2014
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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