PRC-4016 (Icosabutate) Phase I Drug-drug Interaction Study

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PRC-4016 (icosabutate)

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRC-4016 (Icosabutate)	Drug: PRC-4016 (icosabutate); Midazolam, omeprazole, flurbiprofen and simvastatin interaction with PRC-4016. Detailed description under "Study description"; Other Names: Midazolam, omeprazole, flurbiprofen and simvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Blood-sampling	24 h postdose
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.	Blood-sampling	24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Adverse event recording	24 h postdose

Collaborators and Investigators

• Sponsor: Pronova BioPharma

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: February 13, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Estimate): February 20, 2015
• Last Update Submitted That Met QC Criteria: February 13, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Phase I drug-drug interaction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antimetabolites; Gastrointestinal Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Midazolam; Simvastatin; Omeprazole; Flurbiprofen
• Other Study ID Numbers: CTN401614103