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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01979484
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : January 9, 2014
Information provided by (Responsible Party):
Presidio Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Pharmacokinetic Assessments in Healthy Volunteers Drug: PPI-668 capsule Drug: PPI-668 tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

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 capsule
Drug: PPI-668 tablet
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 capsule
Drug: PPI-668 tablet

Primary Outcome Measures :
  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 Outcome Measures :
  1. number of participants with adverse events [ Time Frame: Days 1 - 8 ]
  2. number of participants with increases or decreases in clinical laboratory parameters such as serum albumin, sodium, and chloride levels [ Time Frame: Days 1 - 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01979484

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United States, New York
Buffalo Clinical Research Center
Buffalo, New York, United States, 14202
Sponsors and Collaborators
Presidio Pharmaceuticals, Inc.
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Study Director: Nathaniel Brown, MD Presidio Pharmaceuticals
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Responsible Party: Presidio Pharmaceuticals, Inc. Identifier: NCT01979484    
Other Study ID Numbers: PPI-668-103
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Keywords provided by Presidio Pharmaceuticals, Inc.: