Recruiting
Phase 2

Pharmacogenomic Testing

Sponsor:

Mayo Clinic

Code:

NCT06322238

Conditions

Pharmacogenomic Drug Interaction

Side Effect of Drug

Ineffective Drug Action

Drug Metabolism, Poor, CYP2D6-Related

Drug Metabolism, Poor, CYP2C19-Related

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PGx panel test

Study Details

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

Study ID

NCT06322238

Start date

Dec 1, 2024

Status verified date

Oct, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Subject must be ≥ 18 years old
2. 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.
3. Subject is able and willing to take part and willing to be followed up on for 48 weeks
4. Subject is able to donate saliva
5. Subject has signed informed consent
6. Subject meets requirement for computer access implying computer literacy as measured by active use of the patient portal or their email

Exclusion Criteria:

1. 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
2. Pregnant or lactating (to be verbally confirmed with the patient)
3. Life expectancy estimated to be less than three months as determined by patient receiving hospice care
4. Duration of index drug total treatment length is planned to be less than seven consecutive days.
5. Current inpatients
6. Unable to consent to the study
7. Unwilling to take part
8. Subject has no permanent address
9. Subject has no current primary care provider
10. Subject is, in the opinion of the study coordinator after discussion with participating clinician/pharmacist/investigator, not suitable to participate in the study
11. Patient has a diagnosis of stage 4 or 5 chronic kidney disease (CKD) or is receiving dialysis
12. Patients with advanced liver failure (stage Child-Pugh C) or a diagnosis of liver cirrhosis
13. History of a liver transplant or an allogeneic hematopoietic stem cell transplant
14. DNA sample collected that requires retesting in the event that DNA collected was not sufficient for testing as determined by the laboratory

Study Design

Enrollment

66 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PGx testing arm

placebo comparator: Delayed PGx testing arm

Interventions

PGx panel 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.

Primary outcome measure

  • Adverse Drug Reaction (ADR) [ Time Frame: 48 weeks ]

Central Contacts and Locations

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-10-14.