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

Phase 1

Completed

• Conditions: Pharmacokinetic Assessments in Healthy Volunteers
• Interventions: Drug: PPI-668 tablet; Drug: PPI-668 capsule

• Registration Number: NCT02258321
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2014-10
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-07
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-20
• Last Update Posted: 2015-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PPI-668 capsule followed by tablet	PPI-668 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.
PPI-668 tablet followed by capsule	PPI-668 tablet	On day 1, one 200 mg PPI-668 tablet will be administered. On day 6, two 100 mg PI-668 capsules will be administered.
PPI-668 tablet followed by capsule	PPI-668 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.
PPI-668 capsule followed by tablet	PPI-668 capsule	On day 1, two 100 mg PI-668 capsules will be administered. On day 6, one 200 mg PPI-668 tablet will be administered.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
assessments of adverse events	days 1-8
assessments of composite of clinical laboratory parameters	days 1-8

Trial Locations

Locations (1)

Buffalo Clinical Research Center; 🇺🇸 Buffalo, New York, United States