Healthy
Conditions
Keywords
Phase I drug-drug interaction
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.
Interventions
DRUGPRC-4016 (icosabutate)
Midazolam, omeprazole, flurbiprofen and simvastatin interaction with PRC-4016. Detailed description under Study description
Sponsors
Pronova BioPharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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findings * pregnant or lactating * Poor metabolizers for CYP2C9 or CYP2C19 * subjects previously taken part in or withdrawn from study or subjects that according to investigator should not participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 24 h postdose | Blood-sampling |
| 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. | 24 hours post-dose | Blood-sampling |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Adverse event recording |
Countries
United Kingdom
Outcome results
None listed