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

NCT02367937 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-02-20

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

PRC-4016 (icosabutate)

Midazolam, omeprazole, flurbiprofen and simvastatin interaction with PRC-4016. Detailed description under "Study description"

Sponsors & Collaborators

  • Pronova BioPharma

    lead INDUSTRY

Principal Investigators

  • Joseph Chiesa, MD · Covance

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02367937 on ClinicalTrials.gov