Recruiting

PGX Assay

Sponsor:

Primex Clinical Laboratories, Inc.

Code:

NCT02336269

Conditions

Patients on Medications Metabolized Via CYP450

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Primex's PGX assay is an in vitro, semi automated assay, intended for the determination of certain genes involved in drug metabolism utilizing buccal swabs. Detection of certain genotypes is used as an aid in the selection of appropriate medications based on the individuals' specific genotype and should be used in conjunction with other clinical information. The results from this tests constitutes one parameter in a multicriterion medication selection process, encompassing both clinical and laboratory-based assessments.

Conditions

Patients on Medications Metabolized Via CYP450

Study ID

NCT02336269

Start date

Oct, 2013

Status verified date

Jan, 2015

Completion date

Oct, 2019

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Buccal swab sample prospectively collected under Informed Consent
  • Remnant Buccal swab sample meeting the FDA requirements for use of leftover specimen
  • Samples from at least one of the following groups:
  • specimens from subjects who are on multiple medications of which at least 2 are affected by the pathways tested and the physician made changed to their drug regimen based on the assay interpretations
  • subjects who are on multiple medications of which at least 2 are affected by the pathways tested and the physician made no changes based on the assay interpretations
  • Subjects with Chronic disease
  • Subjects with different ethnic backgrounds
  • Subjects from different geographical areas
  • Apparently healthy subjects
  • Clinical information required per CRF is available

Exclusion Criteria:

- Samples that do not meet all inclusion criteria

Study Design

Enrollment

100000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Clinical Utility of Primex's PGX assay as measured by medication change/no-change by the physician based on Primex's PGX assay results as an aid in the prediction of drug response [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Zohrab Bostanian, MS

8182244235zbostanian@rdi-web.com

Erik Avaniss Aghajani

8187790496erik@primexlab.com

Locations

Research and Development Institute

Recruiting

Van Nuys, California, United States, 91406

Contacts

Zohrab Bostanian, MS

818-224-4235zbostanian@rdi-web.com

More Information

Sponsor

Primex Clinical Laboratories, Inc.

Last update posted

Jan 12, 2015

Last verified

Jan, 2015

Keywords

  • Pharmacogenomics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Primex Clinical Laboratories, Inc. on 2015-01-12.