Effects of Isotretinoin on CYP2D6 Activity
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 4/25/2018 |
Start Date: | July 26, 2016 |
End Date: | July 26, 2026 |
Contact: | Mary F Hebert, PharmD |
Email: | mhebert@uw.edu |
Phone: | 206-616-5016 |
Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases
CYP2D6 activity in adolescent patients.
CYP2D6 activity in adolescent patients.
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
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
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
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