Effects of Isotretinoin on CYP2D6 Activity

CYP2D6 Polymorphism Clinical Trial

Official title:

Effects of Isotretinoin on CYP2D6 Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076021
• Other study ID #: STUDY00002324
• Secondary ID: R01GM124264
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• CYP2D6 Polymorphism

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