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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367937
• Other study ID #: CTN401614103
• Status: Completed
• Phase: Phase 1
• First received: February 9, 2015
• Last updated: February 13, 2015
• Start date: August 2014
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: Pronova BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PRC-4016 (icosabutate)
Midazolam, omeprazole, flurbiprofen and simvastatin interaction with PRC-4016. Detailed description under "Study description"

Locations

Country	Name	City	State
United Kingdom	Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Pronova BioPharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes