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Effects of Isotretinoin on CYP2D6 Activity

Sponsor
University of Washington (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03076021
Collaborator
National Institute of General Medical Sciences (NIGMS) (NIH)
50
Enrollment
1
Location
1
Arm
120
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective, pre-post drug interaction study evaluating an approved drug (Phase 4) with a Phase 1 study design.Prospective, pre-post drug interaction study evaluating an approved drug (Phase 4) with a Phase 1 study design.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effects of Isotretinoin on CYP2D6 Activity
Actual Study Start Date :
Jul 26, 2016
Anticipated Primary Completion Date :
Jul 26, 2026
Anticipated Study Completion Date :
Jul 26, 2026

Arms and Interventions

Arm Intervention/Treatment
Other: Adolescents

dextromethorphan pre- and post isotretinoin

Drug: Isotretinoin
Drug interaction study
Other Names:
  • accutane

    • Drug: dextromethorphan
    Drug interaction study
    Other Names:
  • robitussin pediatric

    		•

    Outcome Measures

    Primary Outcome Measures

    1. CYP2D6 activity [1 week to 6 months]

      DM/DX Metabolic Ratio

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Washington Seattle Washington United States 98195

    Sponsors and Collaborators

    • University of Washington
    • National Institute of General Medical Sciences (NIGMS)

    Investigators

    • Principal Investigator: Mary F Hebert, PharmD, University of Washington

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mary Hebert, Professor of Pharmacy, Adjunct Professor of Obstetrics and Gynecology, University of Washington
    ClinicalTrials.gov Identifier:
    NCT03076021
    Other Study ID Numbers:
    • STUDY00002324
    • R01GM124264
    First Posted:
    Mar 9, 2017
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Dextromethorphan
    Isotretinoin

    Study Results

    No Results Posted as of Sep 29, 2021