Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:

NCT06322238 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 23-008706
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug').

Conditions

Pharmacogenomic Drug Interaction; Side Effect of Drug; Ineffective Drug Action; Drug Metabolism, Poor, CYP2D6-Related; Drug Metabolism, Poor, CYP2C19-Related

Keywords

pharmacogenomics; PGx; CPIC; primary care; drug metabolism; side effects; ineffectiveness; PREPARE-Mayo

Outcome Measures

Primary Outcomes (1)

• Adverse Drug Reaction (ADR)

  The count of participants who experience any of the following ADR's: muscle aches, falling, tripping, fainting, palpations, emotional changes, or physical changes

  48 weeks

Secondary Outcomes (2)

• PREPARE-MAYO Clinicians' and pharmacists' Questionnaire.

  48 weeks

• Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Questionnaire

  48 weeks

Study Arms (2)

PGx testing arm

EXPERIMENTAL

Diagnostic Test: PGx panel test

Delayed PGx testing arm

PLACEBO COMPARATOR

Diagnostic Test: PGx panel test

Interventions

PGx panel test DIAGNOSTIC_TEST

In this prospective, non-randomized, step-wedge design controlled clinical study (PREPARE-MAYO Rochester, Mayo Clinic Health System), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which CPIC guidelines are available.

Delayed PGx testing arm; PGx testing arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Subject must be ≥ 18 years old
• Subject must receive a 1st prescription (meaning no known prescription for this drug in the preceding 12 months) for a drug included in Table 1, which is prescribed to them in routine primary care.
• Subject is able and willing to take part and willing to be followed up on for 48 weeks
• Subject is able to donate saliva
• Subject has signed informed consent
• Subject meets requirement for computer access implying computer literacy as measured by active use of the patient portal or their email

You may not qualify if:

• For the investigational arm only: Previous (direct-to-consumer, or clinical) pharmacogenomic testing that includes any of the genes included in the Focused Pharmacogenomics Panel
• Pregnant or lactating (to be verbally confirmed with the patient)
• Life expectancy estimated to be less than three months as determined by patient receiving hospice care
• Duration of index drug total treatment length is planned to be less than seven consecutive days.
• Current inpatients
• Unable to consent to the study
• Unwilling to take part
• Subject has no permanent address
• Subject has no current primary care provider
• Subject is, in the opinion of the study coordinator after discussion with participating clinician/pharmacist/investigator, not suitable to participate in the study
• Patient has a diagnosis of stage 4 or 5 chronic kidney disease (CKD) or is receiving dialysis
• Patients with advanced liver failure (stage Child-Pugh C) or a diagnosis of liver cirrhosis
• History of a liver transplant or an allogeneic hematopoietic stem cell transplant
• DNA sample collected that requires retesting in the event that DNA collected was not sufficient for testing as determined by the laboratory

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Drug Metabolism, Poor, CYP2D6-Related; Drug Metabolism, Poor, CYP2C19-Related

Study Officials

• Isa Houwink, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: March 21, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)