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

NCT02258321 | Completed Phase 1

• 1 other identifier: PPI-668-104
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetic Assessments in Healthy Volunteers

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)

• assessments of adverse events

  days 1-8

• assessments of composite of clinical laboratory parameters

  days 1-8

Study Arms (2)

PPI-668 tablet followed by capsule

EXPERIMENTAL

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

PPI-668 capsule followed by tablet

EXPERIMENTAL

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

Interventions

PPI-668 tablet DRUG

PPI-668 capsule followed by tablet; PPI-668 tablet followed by capsule

PPI-668 capsule DRUG

PPI-668 capsule followed by tablet; PPI-668 tablet followed by capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Presidio Pharmaceuticals, Inc.: lead

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
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 7, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 22, 2015

Record last verified: 2015-01

Locations

US (1)