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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03076021
Other study ID # STUDY00002324
Secondary ID R01GM124264
Status Completed
Phase Phase 4
First received
Last updated
Start date July 26, 2016
Est. completion date November 27, 2023

Study information

Verified date November 2023
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.


Description:

In this aim, we will conduct a drug-drug interaction study evaluating the effects of 13-cis-retinoic acid on non-induced CYP2D6 activity in adolescent patients. Secondary analysis will evaluate the relationship between retinoid concentrations and CYP2D6 activity in these special populations


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Isotretinoin
Drug interaction study
dextromethorphan
Drug interaction study

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary CYP2D6 activity DM/DX Metabolic Ratio 1 week to 6 months
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