Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00658554

Enrollment

Registered

2008-04-15

Start date

2008-04-30

Completion date

2008-06-30

Last updated

2008-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.

Detailed description

This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design. The primary objective is to obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.

Interventions

DRUGARQ 197

Treatment with ARQ 197

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Subject must provide written informed consent prior to any study related procedures * Subjects must be between the ages of 18 and 65 years * Male participants must have been surgically sterilized * Female participants must have been surgically sterilized or be post menopausal and must have a negative serum pregnancy test * All participants will be phenotypically extensive metabolizers based on their CYP C19 genotype.

Exclusion criteria

* Males who are not surgically sterilized * Females of child-bearing potential who are not surgically sterilized * Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination * Any clinically significant abnormality in the screening laboratory tests or ECG * Received any investigational drugs within four weeks * Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

Design outcomes

Primary

Measure	Time frame
To obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.	May 2008

Secondary

Measure	Time frame
To monitor safety of the three solid states of ARQ 197.	May 2008

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026