Effects of Isotretinoin on CYP2D6 Activity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- CYP2D6 Activity as Measured by the Molar Concentration Ratio of Dextromethorphan (DM)/Dextrophan (DX)
研究概览
简要总结
Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant
- •≥ 12 years
- •Patients with severe acne that are expected to receive isotretinoin for therapeutic reasons
排除标准
- •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 chronic obstructive pulmonary disease,
- •Productive cough,
- •Known kidney disease,
- •Known liver disease,
- •Obesity, body mass index ≥ 30 kg/m2
- •Bipolar disease,
- •Attention deficit disorder,
- •Social phobia,
- •Concurrent or use within 14 days of drugs known to interact with dextromethorphan or cytochrome P450 2D6 (CYP2D6) or drugs known to increase the risk of adverse effects from dextromethorphan
- •Concurrent use of any other product containing dextromethorphan
- •Consuming foods, beverages or dietary supplements known to interact with dextromethorphan or CYP2D6
- •Unable to give written informed consent/assent,
- •Inability to fast for 4 hours prior to study.
- •Wards of the State
研究组 & 干预措施
Adolescents
dextromethorphan pre- and post isotretinoin
干预措施: Isotretinoin (Drug)
Adolescents
dextromethorphan pre- and post isotretinoin
干预措施: dextromethorphan (Drug)
结局指标
主要结局
CYP2D6 Activity as Measured by the Molar Concentration Ratio of Dextromethorphan (DM)/Dextrophan (DX)
时间窗: 1 week to 6 months
dextromethorphan (DM)/dextrophan (DX) molar concentration Metabolic Ratio. The metabolic ratio is unit-less as the molar concentrations cancel out.
次要结局
未报告次要终点
研究者
Mary Hebert
Professor of Pharmacy, Adjunct Professor of Obstetrics and Gynecology
University of Washington