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NCT00658554 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00658554: Completed Phase 1 study, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).

NCT00658554 is a Phase 1 study that has completed, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00658554, a Phase 1 study, has completed, sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA).

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

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

Interventions

  • DRUG ARQ 197

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2008-04
Est. Completion 2008-06
Phase Phase 1

What the finished NCT00658554 record still lists

NCT00658554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 1 intervention - of which ARQ 197 is the first listed.

NCT00658554 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00658554 about?

NCT00658554 is a clinical study titled "Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers". This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.

What is the current status of trial NCT00658554?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2008-04. Estimated completion is 2008-06.

What interventions are being tested in trial NCT00658554?

The interventions under investigation include: ARQ 197 (DRUG).

Who is sponsoring clinical trial NCT00658554?

This trial is sponsored by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA), which has 27 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00658554's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00658554, the US trial registry maintained by the National Library of Medicine. NCT00658554 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.