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Trial record 19 of 163 for:    ISOTRETINOIN

Effects of Isotretinoin on CYP2D6 Activity

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ClinicalTrials.gov Identifier: NCT03076021
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Mary Hebert, University of Washington

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
CYP2D6 Polymorphism Drug: Isotretinoin Drug: dextromethorphan 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Isotretinoin on CYP2D6 Activity
Actual Study Start Date : July 26, 2016
Estimated Primary Completion Date : July 26, 2026
Estimated Study Completion Date : July 26, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Adolescents
dextromethorphan pre- and post isotretinoin
Drug: Isotretinoin
Drug interaction study
Other Name: accutane

Drug: dextromethorphan
Drug interaction study
Other Name: robitussin pediatric




Primary Outcome Measures :
  1. CYP2D6 activity [ Time Frame: 1 week to 6 months ]
    DM/DX Metabolic Ratio



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076021


Contacts
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Contact: Mary F Hebert, PharmD 206-616-5016 mhebert@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Mary F Hebert, PharmD    206-616-5016    mhebert@uw.edu   
Sponsors and Collaborators
University of Washington
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: Mary F Hebert, PharmD University of Washington

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Responsible Party: Mary Hebert, Professor of Pharmacy, Adjunct Professor of Obstetrics and Gynecology, University of Washington
ClinicalTrials.gov Identifier: NCT03076021     History of Changes
Other Study ID Numbers: STUDY00002324
R01GM124264 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After completion of the study, we plan to follow NIGMS/NIH and University of Washington requirements for data sharing.

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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:
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Dextromethorphan
Isotretinoin
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dermatologic Agents