A Phase I, Multicenter, Open-Label, Single-Agent Study to Assess the Pharmacokinetics of Cytochrome P450 Substrates After Treatment With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 17
研究概览
简要总结
The purpose of this study is to evaluate the disease-drug-drug interaction (DDDI) potential of afimkibart (also known as RO7790121). This will be assessed by the characterization of the pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme substrates alone and after administration of afimkibart in participants with moderately to severely active ulcerative colitis (UC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight >= 40kg
- •Agreement to adhere to the contraceptive requirements
- •UC Specific Inclusion Criteria:
- •Confirmed diagnosis of UC with supportive clinical, endoscopic, and histopathological evidence
- •Active UC confirmed by endoscopy (flexible sigmoidoscopy or colonoscopy) extending >=15 cm from the anal verge
- •Moderately to severely active UC, defined as an modified Mayo score of 5 to 9 points, including a Mayo endoscopic subscore of 2 or 3, confirmed through centrally read endoscopy
排除标准
- •Inflammatory Bowel Disease (IBD) Exclusion Criteria:
- •Current diagnosis of Crohn's disease (CD),abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease
- •Presence of an ostomy or ileoanal pouch
- •Current diagnosis or suspicion of primary sclerosing cholangitis
- •Medical History Exclusion Criteria:
- •Lack of peripheral venous access
- •Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
- •History of alcohol, drug, or chemical abuse < 1 year prior to screening
研究组 & 干预措施
Afimkibart Treatment and CYP Cocktail Group
Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase.
干预措施: Dextromethorphan (Drug)
Afimkibart Treatment and CYP Cocktail Group
Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase.
干预措施: Caffeine (Drug)
Afimkibart Treatment and CYP Cocktail Group
Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase.
干预措施: Omeprazole (Drug)
Afimkibart Treatment and CYP Cocktail Group
Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase.
干预措施: Warfarin (Drug)
Afimkibart Treatment and CYP Cocktail Group
Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase.
干预措施: Midazolam (Drug)
Afimkibart Treatment and CYP Cocktail Group
Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase.
干预措施: Afimkibart (Drug)
Afimkibart Treatment and CYP Cocktail Group
Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase.
干预措施: Vitamin K (Other)