NL-OMON55164已完成不适用
A randomised, double blind (sponsor unblinded), placebo-controlled, first time in human study to evaluate the safety, tolerability and pharmacokinetics of single and repeat oral doses and the food effect of GSK2556286 in healthy adult participants - CS0343-190570
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
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 64（—）
入选标准
- •Participant must be 18 to 60 years of age inclusive, at the time of signing the
- •informed consent. Participants aged 51 to 60 years must have received at least
- •one dose of an EMA-approved COVID-19 vaccine at least 3 weeks prior to signing
- •the consent form.
- •Participants who are overtly healthy as determined by medical evaluation
- •including medical history, physical examination, laboratory tests, and cardiac
- •monitoring. A participant with a clinical abnormality or laboratory
- •parameter(s) which is/are not specifically listed in the inclusion or exclusion
- •criteria, outside the normal reference range for the population being studied
- •may be included only if the Investigator in consultation with the Medical
- •Monitor (if required) agree and document that the finding is unlikely to
- •introduce additional risk factors and will not interfere with the study
- •procedures.
- •Note: Screened participants with laboratory values outside of the normal range
- •may be rescreened once for inclusion into the study at the discretion of the
- •Investigator.
- •Body weight *50kg, and body mass index (BMI) within the range 19 to 29.9 kg/m2
- •Male and/or Female Participants:
- •Male participants:
- •A male participant with a female partner of reproductive potential must agree
- •to use contraception as detailed in Appendix 4 of this clinical study protocol
- •during the treatment period and for at least 90 days after the last dose of
- •study treatment and refrain from donating sperm during this period.
- •Female participants:
- •A female participant is eligible to participate if she is not a woman of
- •childbearing potential (WONCBP) as defined in Appendix 4 of this clinical study
- •The participant is able to understand and comply with protocol requirements,
- •instructions and protocol-stated restrictions.
排除标准
- •Significant history of or current, cardiovascular, respiratory (including
- •asthma), hepatic, renal, gastrointestinal, endocrine, haematological,
- •infectious or neurological disorders capable of significantly altering the
- •absorption, metabolism, or elimination of drugs: constituting a risk when
- •taking part in the study or interfering with the interpretation of data.
- •Alanine aminotransferase (ALT) >1.5xupper limit of normal (ULN)
- •Total bilirubin >1.5xULN (isolated total bilirubin >1.5xULN may be acceptable,
- •after consultation with the GSK Medical Monitor, if total bilirubin is
- •fractionated and direct bilirubin <35%).
- •Current or chronic history of liver disease or known hepatic or biliary
- •abnormalities (with the exception of Gilbert*s syndrome or asymptomatic
- •gallstones) or cholecystectomy.
- •Current or past history of significant renal disease including renal stones.
研究者
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