Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00658554|
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : June 19, 2008
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: ARQ 197||Phase 1|
Expanded Access : ArQule has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||June 2008|
- Drug: ARQ 197
Treatment with ARQ 197
- To obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B. [ Time Frame: May 2008 ]
- To monitor safety of the three solid states of ARQ 197. [ Time Frame: May 2008 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658554
|United States, Indiana|
|Covance Clinical Research Unit, Inc.|
|Evansville, Indiana, United States, 47714|
|Principal Investigator:||Ronald M Kimberlin, MD||Covance Clinical Research Unit|