NCT02367937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Aug 2014

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

Enrollment Period

2 months

First QC Date

February 9, 2015

Last Update Submit

February 13, 2015

Conditions

Healthy

Keywords

Phase I drug-drug interaction

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

PRC-4016 (Icosabutate)

EXPERIMENTAL
Drug: PRC-4016 (icosabutate)

Interventions

PRC-4016 (icosabutate)DRUG

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

Also known as: Midazolam, omeprazole, flurbiprofen and simvastatin
PRC-4016 (Icosabutate)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • males or females
  • any ethnic origin
  • age 18-60 years
  • BMI 8.0 - 35.0 kg/m2
  • generally good health
  • signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

icosabutateMidazolamOmeprazoleFlurbiprofenSimvastatin

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingBenzimidazolesPropionatesAcids, AcyclicCarboxylic AcidsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Joseph Chiesa, MD

    Covance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 20, 2015

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 20, 2015

Record last verified: 2015-02

Locations

GB(1)