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Trial record 7 of 12 for:    ravidasvir

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

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ClinicalTrials.gov Identifier: NCT02258321
Recruitment Status : Completed
First Posted : October 7, 2014
Last Update Posted : January 22, 2015
Sponsor:
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, T003.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official 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
Study Start Date : October 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

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



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. assessments of adverse events [ Time Frame: days 1-8 ]
  2. assessments of composite of clinical laboratory parameters [ 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
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT02258321


Locations
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United States, New York
Buffalo Clinical Research Center
Buffalo, New York, United States, 14202
Sponsors and Collaborators
Presidio Pharmaceuticals, Inc.
Investigators
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Study Director: Nathaniel Brown, MD Presidio Pharmaceuticals

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Responsible Party: Presidio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02258321     History of Changes
Other Study ID Numbers: PPI-668-104
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015