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

Presidio Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetic Assessments in Healthy Volunteers

Treatments

Drug: PPI-668 tablet

Drug: PPI-668 capsule

Study type

Interventional

Funder types

Industry

Identifiers

PPI-668-104

Details and patient eligibility

About

This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet, T003.

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.