NCT01979484

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

1 month

First QC Date

October 28, 2013

Last Update Submit

January 7, 2014

Conditions

Pharmacokinetic Assessments in Healthy Volunteers

Keywords

bioavailability

Outcome Measures

Primary Outcomes (3)

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

    Days 1 - 8

  • PPI-668 maximum observed plasma concentration (Cmax)

    Days 1 - 8

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

    Days 1 - 8

Secondary Outcomes (2)

  • number of participants with adverse events

    Days 1 - 8

  • number of participants with increases or decreases in clinical laboratory parameters such as serum albumin, sodium, and chloride levels

    Days 1 - 8

Study Arms (2)

PPI-668 capsule followed by tablet

EXPERIMENTAL

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 capsuleDrug: PPI-668 tablet

PPI-668 tablet followed by capsule

EXPERIMENTAL

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 capsuleDrug: PPI-668 tablet

Interventions

PPI-668 capsuleDRUG
PPI-668 capsule followed by tabletPPI-668 tablet followed by capsule
PPI-668 tabletDRUG
PPI-668 capsule followed by tabletPPI-668 tablet followed by capsule

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
  • Must be between 18 and 55 years of age, inclusive.
  • 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.
  • Must have a calculated body mass index (BMI) of 18.0 to 29.9 kg/m2.
  • Must be HIV-1 antibody negative.
  • Must be hepatitis B (HBV) surface antigen negative.
  • Must be hepatitis C (HCV) antibody negative.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buffalo Clinical Research Center

Buffalo, New York, 14202, United States

Location

MeSH Terms

Interventions

ravidasvir

Study Officials

  • Nathaniel Brown, MD

    Presidio Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 8, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

US(1)