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| ID | Type | Description | Link |
|---|---|---|---|
| R01GM124264 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescents | Other | dextromethorphan pre- and post isotretinoin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isotretinoin | Drug | Drug interaction study |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| CYP2D6 Activity as Measured by the Molar Concentration Ratio of Dextromethorphan (DM)/Dextrophan (DX) | dextromethorphan (DM)/dextrophan (DX) molar concentration Metabolic Ratio. The metabolic ratio is unit-less as the molar concentrations cancel out. | 1 week to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary F Hebert, PharmD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37864393 | Result | 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. 2024 Mar;90(3):759-768. doi: 10.1111/bcp.15938. Epub 2023 Nov 21. |
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After completion of the study, we plan to follow NIGMS/NIH and University of Washington requirements for data sharing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Individuals Expected to Receive Isotretinoin for Therapeutic Reasons | Each subject had 2 study days, one pre-isotretinoin treatment and one while receiving isotretinoin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-isotretinoin |
| |||||||||||||
| Isotretinoin |
|
All subjects that completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Individuals expected to receive isotretinoin for therapeutic reasons |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Collected directly from subjects |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CYP2D6 Activity as Measured by the Molar Concentration Ratio of Dextromethorphan (DM)/Dextrophan (DX) | dextromethorphan (DM)/dextrophan (DX) molar concentration Metabolic Ratio. The metabolic ratio is unit-less as the molar concentrations cancel out. | The number of subjects included in the analysis is less than the number that completed the study because only cytochrome P450 extensive metabolizers were included in the analysis. Each person served as their own control (pre-isotretinoin and with isotretinoin). Pre-isotretinoin study was completed prior to starting isotretinoin and then the same study was completed after the subject had been on isotretinoin for 1 week to 6 months. | Posted | Geometric Mean | 90% Confidence Interval | Ratio | 1 week to 6 months |
|
1 week to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-isotretinoin | Individuals expected to receive isotretinoin for therapeutic reasons |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Hebert | University of Washington | 206-616-5016 | mhebert@u.washington.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2017 | Jan 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2017 | Jan 3, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2018 | Jan 3, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D015474 | Isotretinoin |
| D003915 | Dextromethorphan |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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Prospective, pre-post drug interaction study evaluating an approved drug (Phase 4) with a Phase 1 study design.
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| dextromethorphan | Drug | Drug interaction study |
|
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | With Isotretinoin | Individuals receiving isotretinoin for therapeutic reasons. |
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | With Isotretinoin | Individuals receiving isotretinoin for therapeutic reasons | 0 | 33 | 0 | 33 | 0 | 33 |
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| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |