A Double-Blind, Sponsor-Unblinded, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single-Ascending Doses of JZP047 and an Open-Label Food Effect Study of JZP047 in Healthy Male and Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting Treatment-emergent Adverse Events (Part A)
研究概览
简要总结
This is a Phase 1, double-blind, sponsor-unblinded, randomized, placebo-controlled study designed to characterize the safety, tolerability, and PK of JZP047 in healthy participants following single-ascending doses of study intervention. Additionally, the effect of food on PK following a single dose of JZP047 will be assessed through comparison of PK between the fed and fasted states.
详细描述
The study will consist of 2 parts: a single-dose ascending part (Part A [SAD] and a single dose under fed conditions part (Part B [Fed PK]).
The study design for Part A will be double-blind, sponsor-unblinded, randomized, and placebo-controlled. Part B, the single dose under fed conditions, will have an open-label study design.
Part A will characterize safety, tolerability, and PK following single doses of JZP047 and matching placebo in healthy male and female participants. Part B will explore the effect of food on a single dose of JZP047 in healthy male and female participants in the fed state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Healthy participants 18 to 55 years of age, willing and able to comply with study requirements.
- •Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 120 days after the last dose of study intervention:
- •Refrain from donating sperm.
- •Use contraception/barrier as follows:
- •Use a male condom with female partner and use of an additional highly effective contraceptive method with a failure rate of < 1% per year and should also be advised of the benefit of a female partner using a highly effective method of contraception, as a condom may break or leak, when having sexual intercourse with a woman of childbearing potential (WOCBP) who is currently not pregnant.
- •Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.
- •Female participants are eligible to participate if:
- •She is a woman of nonchildbearing potential (WONCBP).
- •Pregnancy testing will be performed prior to administration of study intervention to confirm female participants are not pregnant.
- •Participants are excluded from the study if any of the following criteria apply:
- •History of or presence of clinically significant medical illness or disorder or have a medical issue that may interfere with absorption, distribution, metabolism, or excretion of drugs..
- •History or presence of clinically significant allergy (other than seasonal allergies that do not require treatment during the study) or clinically significant allergy to adhesive bandages, adhesive dressing, ECG patches, or medical tape.
- •History (within 5 past years) or presence of a diagnosis of alcohol abuse, a substance abuse disorder, known drug dependence, or seeking of treatment for an alcohol- or substance abuse-related disorder.
- •Current diagnosis of or receiving treatment for depression; past (within 5 years) clinically significant major depressive episode.
- •History of suicide attempt, current suicidal risk as determined from history, or presence of active suicidal ideation.
- •Presence of any other condition that will cause a risk to participants if they participate in the study as determined by the investigator.
- •Poor peripheral venous access or history of fainting (or passing out) during blood draws.
- •Use or intent to use any prescription medications or nonprescription drugs (including vitamins, recreational drugs, and dietary or herbal supplements) within 14 days or for 5 half-lives, whichever is longer prior to Check-in and throughout the conduct of the study.
排除标准
- 未提供
研究组 & 干预措施
Part A: JZP047
Healthy participants who are randomized to JZP047.
干预措施: JZP047 (Drug)
Part A: Placebo
Healthy participants who are randomized to placebo.
干预措施: Placebo (Other)
Part B: JZP047
Healthy participants who will receive JZP047.
干预措施: JZP047 (Drug)
结局指标
主要结局
Number of Participants Reporting Treatment-emergent Adverse Events (Part A)
时间窗: Baseline up to Day 90
Number of Participants Reporting Treatment-emergent Adverse Events (Part B)
时间窗: Baseline up to Day 90
Number of Participants Who Discontinued The Study (Part A)
时间窗: Baseline up to Day 90
Number of Participants Who Discontinued The Study (Part B)
时间窗: Baseline up to Day 90
Pharmacokinetic Parameter Maximum Concentration (Part A)
时间窗: Up to 90 days
Pharmacokinetic Parameter Time to Maximum Concentration and Time Before the Start of Absorption (Part A)
时间窗: Up to 90 days
Pharmacokinetic Parameter Terminal Elimination Half-life (Part A)
时间窗: Up to 90 days
Pharmacokinetic Parameter Terminal Elimination Rate Constant (Part A)
时间窗: Up to 90 days
Pharmacokinetic Parameter Volume of Distribution During Terminal Phase (Part A)
时间窗: Up to 90 days
Pharmacokinetic Parameter Oral Clearance (Part A)
时间窗: Up to 90 days
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (Part A)
时间窗: Up to 90 days
Area under the concentration-time curve from time 0 to 24 (AUC0-24), 0 to last measurable concentration (AUClast), and 0 to infinity (AUC∞) will be assessed.
Pharmacokinetic Parameter Percentage of The Area Under the Concentration-Time Curve From Time Infinity Due to Extrapolation From The Last Quantifiable Concentration to Time Infinity (Part A)
时间窗: Up to 90 days
次要结局
- Dose Proportionality of JZP047 Cmax (Part A)(Up to 90 days)
- Dose Proportionality of JZP047 AUC0-last and AUC∞(Up to 90 days)
- The Effect of Food On The Single Dose PK of JZP047 Cmax(Up to 90 days)
- The Effect of Food On The Single Dose PK of JZP047 AUC0-last and AUC∞(Up to 90 days)