NCT00651638

Brief Summary

To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2008

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

March 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

June 19, 2008

Status Verified

June 1, 2008

Enrollment Period

2 months

First QC Date

March 27, 2008

Last Update Submit

June 18, 2008

Conditions

Healthy

Keywords

PK and safety profile of ARQ 197

Outcome Measures

Primary Outcomes (1)

  • To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype

    May 2008

Secondary Outcomes (1)

  • To assess the effect of other CYP genotypes on the safety profile and PK profile of ARQ 197

    May 2008

Interventions

Treatment with ARQ 197DRUG

Treatment with ARQ 197

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must provide written informed consent prior to any study related procedures
  • Subjects must be between the ages of 18 and 65 years old
  • Male participants must be surgically sterilized
  • Female participants must be surgically sterilized or post menopausal and must have a negative serum pregnancy test. Post Menopausal is defined as at least one year without menses.
  • Subject must, in the opinion of the Investigator, be willing and able to complete the study procedures

You may not qualify if:

  • Subject must provide written informed consent prior to any study related procedures
  • Subjects must be between the ages of 18 and 65 years old
  • Male participants must be surgically sterilized
  • Female participants must be surgically sterilized or post menopausal and must have a negative serum pregnancy test. Post Menopausal is defined as at least one year without menses.
  • Subject must, in the opinion of the Investigator, be willing and able to complete the study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit, Inc.

Evansville, Indiana, 47714, United States

Location

MeSH Terms

Interventions

TherapeuticsARQ 197

Study Officials

  • Ronald Kimberlin, MD

    Covance Clinical Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2008

First Posted

April 3, 2008

Study Start

March 1, 2008

Primary Completion

May 1, 2008

Study Completion

June 1, 2008

Last Updated

June 19, 2008

Record last verified: 2008-06

Locations

US(1)