NCT04551586已完成1 期
A Phase 1 Study to Assess the Relative Bioavailability of ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Relative Bioavailability Of ACH-0145228 Immediate Release Tablet And Powder-In-Capsule
研究概览
简要总结
This will be an open-label, 3-sequence, 3-period crossover study in healthy adult participants to assess the relative bioavailability of ACH-0145228 when administered as an immediate release tablet versus powder-in-capsule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening.
- •No clinically significant history or presence of electrocardiogram findings at screening.
- •Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
- •Female participants must be of non-childbearing potential and need not employ a method of contraception.
排除标准
- •Clinically significant laboratory abnormalities.
- •History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
- •History or presence of drug or alcohol abuse within previous 2 years, current tobacco user, and positive drugs-of-abuse screen and alcohol screen at screening or Day -1 of Period
- •History or presence of clinically significant seizures, head injury, or head trauma.
- •History of procedures that could alter absorption or excretion of orally administered drugs.
- •History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
- •A history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
- •Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1 or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing.
- •Is a female of childbearing potential.
- •Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, and receipt of blood products within 6 months prior to first dosing.
- •Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever is longer.
结局指标
主要结局
Relative Bioavailability Of ACH-0145228 Immediate Release Tablet And Powder-In-Capsule
时间窗: Up to 72 hours postdose
Relative bioavailability will be measured by the ratio of the area under the concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf).
次要结局
- Area Under The Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions(Up to 72 hours postdose)
- Cmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions(Up to 72 hours postdose)
- AUC0-inf Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions(Up to 72 hours postdose)
- AUC0-inf Of ACH-0145228 Powder-in-capsule Under Fasted Conditions(Up to 72 hours postdose)
- Maximum Observed Concentration (Cmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions(Up to 72 hours postdose)
- Tmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions(Up to 72 hours postdose)
- Time To Maximum Observed Concentration (Tmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions(Up to 72 hours postdose)
- AUC0-t Of ACH-0145228 Powder-in-capsule Under Fasted Conditions(Up to 72 hours postdose)
- Number Of Participants With Treatment-emergent Adverse Events(Day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration))
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Sublingual vs IV Atropine Bioavailability StudyToxic Effect of Organophosphate and Carbamate InsecticidesNCT04290039Biomedical Advanced Research and Development Authority15
已完成
1 期
Relative Drug Exposures Of Two Formulations of PF-02341066HealthyNCT00939731Pfizer24
已完成
1 期
Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy ParticipantsHealthyNCT04940559Alexion Pharmaceuticals, Inc.26
已完成
1 期
A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet FormulationsRelative BioavailabilityNCT04686669Forendo Pharma Ltd12
已完成
1 期
Relative Bioavailability of Two Tepotinib Film-Coated Tablet Formulations in Healthy VolunteersHealthyNCT03021642Merck KGaA, Darmstadt, Germany24