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

A

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: ARQ 197

Study type

Interventional

Funder types

Industry

Identifiers

NCT00658554
ARQ 197-113

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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