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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of ARQ 197 in Healthy Volunteers to Assess the Pharmacokinetic (PK) Profile in Extensive and Poor Metabolizers as Defined by Cytochrome P450 2C19 (CYP 2C19) Genotype

NCT00651638

Healthy

COMPLETED PHASE1

A Study to Compare Two Tablet Formulations of Study Medicine Atirmociclib in Healthy Participants

NCT07130097

Healthy Participant

COMPLETED PHASE1

Bioequivalence Study in Healthy Volunteers

NCT00387985

Healthy

COMPLETED PHASE1

Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.

NCT02624557

Hepatic Impairment

COMPLETED PHASE1

Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers

NCT02228707

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ARQ 197

Treatment with ARQ 197

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes