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CompletedNCT01979484Updated Jan 9, 2014

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

A Phase 1 interventional study of PPI-668 capsule and PPI-668 tablet in Pharmacokinetic Assessments in Healthy Volunteers, sponsored by Presidio Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-09.

Sponsored by Presidio Pharmaceuticals, Inc. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Pharmacokinetic Assessments in Healthy Volunteers

Keywords

  • bioavailability
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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.
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

Interventions

  • DrugPPI-668 capsule
  • DrugPPI-668 tablet
05

What researchers measure

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. 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

06

Study locations

1 site
  • Buffalo Clinical Research Center
    Buffalo, New York 14202, United States
07

Registry details

Key details

Study ID
NCT01979484
Lead sponsor
Presidio Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Nov 8, 2013
Start date
Oct 2013
Primary completion
Nov 2013
Completion
Dec 2013
Last update
Jan 9, 2014

Study contacts

Nathaniel Brown, MD
study director · Presidio Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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