CYP2D6 Polymorphism Clinical Trial
Official title:
Effects of Isotretinoin on CYP2D6 Activity
Verified date | November 2023 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.
Status | Completed |
Enrollment | 36 |
Est. completion date | November 27, 2023 |
Est. primary completion date | November 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: - Non-pregnant - = 12 years - Patients with severe acne that are expected to receive isotretinoin for therapeutic reasons Exclusion Criteria: - Weight < 80 lbs - Allergy or adverse reaction to dextromethorphan, vitamin A or isotretinoin - Pregnant or planning to become pregnant - Unable to follow isotretinoin risk evaluation and mitigation strategies (REMS) program (also known as iPLEDGE program) - Chronic or persistent cough accompanying asthma, smoking or COPD, - Productive cough, - Fever, - Known kidney disease, - Known liver disease, - Diabetes - Obesity, BMI = 30 kg/m2 - Bipolar disease, - Attention deficit disorder, - Social phobia, - Concurrent or use within 14 days of drugs known to interact with DM or CYP2D6 or drugs known to increase the risk of adverse effects from DM - Concurrent use of any other product containing dextromethorphan - Consuming foods, beverages or dietary supplements known to interact with DM or CYP2D6 - Unable to give written informed consent/assent, - Inability to fast for 4 hours prior to study. - Wards of the State |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute of General Medical Sciences (NIGMS) |
United States,
Zhao Y, Vary JC Jr, Yadav AS, Czuba LC, Shum S, LaFrance J, Huang W, Isoherranen N, Hebert MF. Effect of isotretinoin on CYP2D6 and CYP3A activity in patients with severe acne. Br J Clin Pharmacol. 2023 Oct 20. doi: 10.1111/bcp.15938. Online ahead of prin — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CYP2D6 activity | DM/DX Metabolic Ratio | 1 week to 6 months |
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