A Phase I, Open-Label Study to Assess the Effects of PRC-4016 (Icosabutate) on the Pharmacokinetics of Midazolam, Omeprazole, Flurbiprofen and Simvastatin in Healthy Male/Female Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Peak plasma concentration for effect of PRC-4016 at steady state on the PK of CYP3A substrates (midazolam, simvastatin), a CYP2C9 substrate (omeprazole) and a CYP2C19 substrate (flurbiprofen) in healthy male/female subjects.
Study Overview
Brief Summary
The aim of the study is to evaluate the effect of PRC-4016 at steady state on the pharmacokinetics (PK) of cytochrome P450 (CYP) 3A substrates (midazolam, simvastatin), a CYP2C9 substrate (omeprazole) and a CYP2C19 substrate (flurbiprofen) in healthy male/female subjects.
Detailed Description
Day 1: Subject will receive single oral doses of 2.5 mg midazolam, 20 mg omeprazole and 50 mg flurbiprofen morning Day 2: Subject will receive a single oral dose of 40 mg simvastatin on the morning of Day 2. Day 4: Subjects will commence the multiple-dose regimen for PRC-4016 (600 mg once daily) for 11 days. Day 12: Subjects will be given single oral doses of 2.5 mg midazolam, 20 mg omeprazole and 50 mg flurbiprofen co-administered with 600 mg PRC-4016.
Day 13, subjects will be given a single oral dose of 40 mg simvastatin co-administered with 600 mg PRC-4016.
All subjects will return for a post-study visit 7 to 10 days after their final dose.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •males or females
- •any ethnic origin
- •age 18-60 years
- •BMI 8.0 - 35.0 kg/m2
- •generally good health
- •signed informed consent
Exclusion Criteria
- •males or females not willing to use appropriate contraception
- •recent blood donation
- •recent blood received
- •high consumption of alcohol
- •high consumption og tobacco
- •subjects who have engaged in heavy exercise last two weeks
- •prescribed systemic or topical medication taken recently, or supplements/remedies interfering with study procedures or safety
- •other medication known to alter drug absorption or elimination
- •abnormal hearth rate or blood pressure
- •significant history of drug allergy or hypersensitivity to treatment ingredients
- •other significant medical history or physical findings
- •pregnant or lactating
- •Poor metabolizers for CYP2C9 or CYP2C19
- •subjects previously taken part in or withdrawn from study or subjects that according to investigator should not participate
Arms & Interventions
PRC-4016 (Icosabutate)
Intervention: PRC-4016 (icosabutate) (Drug)
Outcomes
Primary Outcomes
Peak plasma concentration for effect of PRC-4016 at steady state on the PK of CYP3A substrates (midazolam, simvastatin), a CYP2C9 substrate (omeprazole) and a CYP2C19 substrate (flurbiprofen) in healthy male/female subjects.
Time Frame: 24 hours post-dose
Blood-sampling
Area under curve for effect of PRC-4016 at steady state on the PK of CYP3A substrates (midazolam, simvastatin), a CYP2C9 substrate (omeprazole) and a CYP2C19 substrate (flurbiprofen) in healthy male/female subjects.
Time Frame: 24 h postdose
Blood-sampling
Secondary Outcomes
- Number of participants with adverse events as a measure of safety and tolerability of PRC-4016 co-administered with midazolam, omeprazole, flurbiprofen and simvastatin in healthy male/female subjects.(24 h postdose)