NL-OMON51382已完成不适用
A Phase 1, Open-Label, Fixed Sequence Drug-Drug Interaction Study to Assess the Effect of Multiple Doses of Oral THB001 on the Pharmacokinetics of Oral Caffeine, Omeprazole, and Midazolam (CYP1A2, CYP2C19 and CYP3A4 probe substrates) in Healthy Volunteers - CS0376-210320
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subjects must understand the nature of the study and must provide signed and
- •dated written informed consent in accordance with local regulations before the
- •conduct of any study-related procedures.
- •2. Healthy as determined by the Investigator, based on a medical evaluation
- •including medical history, physical examination, laboratory tests and ECG
- •recording. A subject with a clinical abnormality or laboratory parameters
- •outside the reference range for the population being studied may be included
- •only if, in the opinion of the Investigator, the finding is (a) unlikely to
- •introduce additional risk to the subject, (b) will not interfere with study
- •procedures or confound study results, and (c) is not otherwise exclusionary
- •(see Exclusion Criteria).
- •3. Vasectomized men and women, age 18-65 years inclusive at will be enrolled.
- •Women of child-bearing potential must agree not to attempt to become pregnant
- •and to use a highly effective form of hormonal (excluding oral contraceptives)
- •or non-hormonal birth control, which entails the use of a non-hormonal
- •intra-uterine device/system in combination with a barrier method (e.g. condom,
- •diaphragm, cervical cap with spermicide) or abstinence during the study and for
- •90 days after the (last) study drug administration. Postmenopausal women must
- •have had >=12 months of spontaneous amenorrhea (with documented
- •follicle-stimulating hormone (FSH) >=30 mIU/mL). Surgically sterile women are
- •defined as those who have had a hysterectomy, bilateral ovariectomy, or
- •bilateral tubal ligation. Women who are surgically sterile must provide
- •documentation of the procedure by an operative report or by ultrasound. All
- •women must have a negative pregnancy test result on Day 1 before (first)
- •administration of study medication. Male subjects must have had a vasectomy at
- •least 4 months prior to the Screening Visit and must have a documented
- •post-surgical follow up to confirm success of the vasectomy. They must also
- •agree to use a condom from Day 1 until 90 days after the last dose of study.
排除标准
- •1. A positive urine drug screen/alcohol breath test at Screening or Day -1.
- •2. A positive Hepatitis B surface antigen or positive Hepatitis C antibody
- •result at screening.
- •3. A positive test for human immunodeficiency virus (HIV) antibody at screening.
- •4. Alanine aminotransferase, aspartate aminotransferase, or total bilirubin
- •levels greater than the upper limit of normal (ULN) at Screening or Day -1. One
- •test result up to 1.25 x the ULN is allowed. One retest at Screening and on Day
- •-1 is allowed. Subjects with Gilbert*s Syndrome are permitted to have total
- •bilirubin values outside the 1.25 x the ULN, as judged by the Investigator as
- •long as the AST and ALT are within normal limits (WNL).
- •5. Hemoglobin, Platelet count, or White blood cell count below the lower limit
- •of normal LLN at Screening. Hemoglobin, Platelet count, or White blood cell
- •count below the LLN on Day -1. One retest is allowed at each visit.
- •6. Serum creatinine greater than the ULN at Screening or Day -1. One retest is
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