Investigating how genetics affect the activation of ACE inhibitors
Genetic Determinants of ACEI Prodrug Activation
This study is trying to see how genetics affect how well a heart medication called enalapril works in healthy adults, to help make treatment better for everyone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT03051282 on ClinicalTrials.gov |
What this trial studies
This study examines the genetic factors that influence the activation of angiotensin-converting enzyme inhibitors (ACEIs), specifically focusing on the prodrug enalapril. It aims to understand why responses to ACEI treatment vary among individuals, which can lead to therapeutic failures or side effects. Healthy volunteers aged 18-55 will be recruited to participate, and their genetic profiles will be analyzed to determine their impact on drug metabolism. The findings could help tailor ACEI therapy to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male and female volunteers aged 18-55 with no significant medical conditions.
Not a fit: Patients with known medical conditions that contraindicate the use of enalapril or those who are underweight may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to more personalized and effective ACEI treatments for patients with hypertension and related conditions.
How similar studies have performed: While the specific genetic determinants of ACEI activation have not been extensively studied, similar pharmacogenomic approaches have shown promise in optimizing drug therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must be male and female (50:50) between the ages of 18-55 years * Females must have a negative urine pregnancy test prior to the study * All subjects must have no clinically significant diseases or clinically significant abnormal laboratory values as assessed during the screening medical history, nursing assessment, and laboratory evaluations * Informed consent must be signed by the eligible subject prior to the initiation of any study procedures Exclusion Criteria: * The presence of a known medical condition that would preclude the use of enalapril * The presence of any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion. * A positive urine pregnancy test in the MCRU prior to the study * No subjects weighing under 50 kg will be selected * The lack of use of acceptable methods of birth control unless abstinent * Subjects who regularly take medications, vitamins, herbal supplements * The use of any illicit drugs or habitual consumption of large quantities of ethanol (\>3 drinks/day) * The consumption of grapefruit or grapefruit juice a week prior to, and during the study * Asians will not be included in the study as the CES1 SNP G143E is absent in this population * Subjects hypersensitive to enalapril * Subject with a history of angioedema * Smokers
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Haojie Zhu, PhD
- Email: hjzhu@med.umich.edu
- Phone: 7347638449
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.