A Phase 1 interventional study of PPI-668 and Midazolam 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 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-26.
Sponsored by Presidio Pharmaceuticals, Inc. · Phase 1, Interventional, and Basic science
The primary objectives of the study are to:
Women of non-childbearing potential or men who agree to utilize adequate contraception throughout the study
Women of non-childbearing potential must be one of the following:
Male subjects who are not surgically sterile must agree to use one of the following birth control methods if sexually active:
Exclusion Criteria:
Positive results on any of the following tests at Screening or Day -1:
urine pregnancy (women only), urine drugs of abuse and alcohol, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody
potential effects of PPI-668 on midazolam pharmacokinetics
Drug: PPI-668 · Drug: Midazolam
potential effects of PPI-668 on omeprazole pharmacokinetics
Drug: PPI-668 · Drug: Omeprazole
potential effects of PPI-668 on telaprevir pharmacokinetics
Drug: PPI-668 · Drug: Telaprevir
Midazolam area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)
Time frame: Days 1-6
Midazolam maximum observed plasma concentration (Cmax)
Time frame: Days 1-6
Omeprazole area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)
Time frame: Days 1-6
Omeprazole maximum observed plasma concentration (Cmax)
Time frame: Days 1-6
Telaprevir area under the plasma concentration-time curve from time 0 to 24 hours after dosing (AUC0-24)
Time frame: Days 1-12
Telaprevir maximum observed plasma concentration (Cmax)
Time frame: Days 1-12
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Presidio Pharmaceuticals, Inc.