NL-OMON48364已完成不适用
A Phase I, randomized, double-blind, placebo-controlled, single-center study to evaluate the safety, tolerability, pharmacokinetics, including the effect of food, and pharmacodynamics of single and multiple ascending oral doses of GLPG3312, in adult, healthy subjects. - GLPG3312-CL-101 SAD/MAD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 100
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
- •- Male or female between 18 to 55 years of age (extremes included), on the date
- •of signing the ICF. Females should be of non-childbearing potential as defined
- •in the protocol.
- •- A body mass index (BMI) between 18 to 30 kg/m2, inclusive.
- •- Subject must be able and willing to comply with restrictions on prior
- •medication.
- •- Male subjects with female partners of childbearing potential must be willing
- •to comply with contraceptive methods.
排除标准
- •- Positive serology for HBsAg, or HCV, or history of hepatitis from any cause
- •with the exception of hepatitis A that was resolved at least 3 months prior to
- •first dosing of the IMP.
- •- History of, or a current immunosuppressive condition (e.g. HIV infection).
- •- Having any illness judged by the investigator as clinically significant, in
- •the 3 months prior to first dosing of the IMP.
- •- Any history, or current sign or symptom of a cardiovascular, renal, or
- •metabolic bone disease or disease of bone remodeling, or any history of
- •endocrine disease, including an abnormal laboratory result for prespecified
- •clinical laboratory safety parameters related to these conditions.
- •- History of malignancy within the past 5 years prior to screening with the
- •exception of excised and curatively treated nonmetastatic cell carcinoma of the
- •skin or carcinoma in situ of cervix which is considered cured with minimal risk
- •of recurrence.
- •- Significant blood loss (including blood donation >450 mL), or transfusion of
- •any blood product within 12 weeks prior to screening.
- •- Treatment with any medication (including over-the-counter and/or prescription
- •medication, dietary supplements, nutraceuticals, vitamins and/or herbal
- •supplements) except occasional paracetamol (maximum dose of 2 g/day and a
- •maximum of 10 g/ 2 weeks) in the last 2 weeks or 5 half-lives of the drug,
- •whichever is longer, prior to the first dosing of the IMP.
- •- Active drug abuse or alcohol abuse (alcohol abuse defined as regular weekly
- •intake of more than 14 units) within 2 years prior to first IMP administration.
- •- Active smoker and/or has used nicotine or nicotine-containing products within
- •the past 6 months before the first IMP administration.
- •- Regular consumption of a large quantity of caffeinated coffee, tea (> 6 cups
- •per day) or equivalent.
- •- Concurrent participation or participation in a drug, drug/device or biologic
- •investigational research study within 12 weeks or 5 half-lives of the IMP,
- •whichever is longer, prior to first dosing of the IMP.
研究者
相似试验
已完成
1 期
A study to evaluate the safety, tolerability, processing by the body, and response of the body to the drug VK2735 in healthy adultson-alcoholic steatohepatitis (NASH)Digestive SystemOther specified inflammatory liver diseasesISRCTN47896018Viking Therapeutics, Inc.88
Unknown
1 期
A phase I clinical trial to study the safety tolerability, pharmacokinetics, food effect and pharmacodynamics of a new compound P7435 in in healthy, overweight and/or obese subjectsCTRI/2012/05/002691Piramal Healthcare Limited96
进行中（未招募）
1 期
Safety, tolerability, pharmacokinetics, and pharmacodynamics of single/multiple doses of IMVT-1402 in healthy participants and participants with autoimmune diseasesISRCTN11659633Immunovant Sciences GmbH168
招募中
不适用
A phase I, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of single and multiple ascending doses of GDC-6599 and the effect of food on the pharmacokinetics and pharmacodynamics of GDC-6599 in healthy adult subjectsAsthma10024970NL-OMON52277Genentech, Inc.92
招募中
1 期
Phase I Single-Administration Study of TKT001-SHealthy adult malesJPRN-jRCT2071230046Kai Megumi16