A Single-center, Open-label, Single-dose, Three-period, Fixed Sequence Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules Compared to the Original Formulation of NPT 2042 Soft-Gelatin Capsules Administered Orally to Healthy Adult Participants With Co-administered Agent
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
研究概览
简要总结
A Single-center, Open-label, Single-dose, Three-period, Fixed Sequence Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between 19 and 65 years of age, inclusive.
- •Body mass index (BMI) of 18 to 35 kg/m2, inclusive, using the following formula: weight (kg)/[height (m)]
- •A minimum body weight of 50 kg for males and 45 kg for females.
- •All females must have a negative serum pregnancy test at Screening and a negative serum pregnancy test upon admission to the clinical research center.
- •Females must be of non-child-bearing potential.
- •Male participants with female partners of reproductive potential must agree to protocol specifications.
排除标准
- •Clinically significant acute illness within 2 weeks prior to Day -
- •Presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
- •Presence of an active malignancy or a malignancy of any type within the past 5 years, other than squamous cell or basal cell carcinoma of the skin.
- •Clinically significant acute or chronic infection or known inflammatory condition.
- •Personal or family history of long QT syndrome.
- •History or evidence of adverse symptoms associated with phlebotomy or blood donation
- •History of clinically significant orthostatic hypotension or any vasovagal syncope.
- •Plans for surgery or other medical procedures during the study.
- •Clinically significant past or current medical or surgical history that could interfere with treatment.
- •Participation in an investigational drug or device study within 30 days or five half-lives, whichever is longer [90 days for biologics], prior to dosing.
- •Presence of clinically significant illness or abnormality on physical examination.
- •Presence of clinically significant ECG abnormality at Screening, including any QT interval corrected for heart rate (QTc) using Fridericia formula (QTcF) ≥470 msec.
- •Ongoing liver disease or unexplained liver function test (LFT) elevations, defined as alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), or alkaline phosphatase (ALP) greater than the upper limit of normal (ULN).
- •Any other clinically significant laboratory results, as judged by the investigator.
- •History or presence of clinically significant hypersensitivity (e.g. systemic or cutaneous) as judged by the investigator to NPT
- •History of substance abuse or current use of any drugs of abuse.
- •Blood donation of >500 mL or more within 56 days prior to Day -
- •Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.
研究组 & 干预措施
NPT 2042 80mg (Reference formulation) in Fasted State
NPT 2042 80mgSingle-dose, reference formulation, given in fasted state.
干预措施: NPT 2042 (Reference formula/Formulation 1) (Drug)
NPT 2042 80mg (Test formulation) in Fasted State
NPT 2042 80mgSingle-dose, test formulation, given in fasted state.
干预措施: NPT 2042 (Test formula/Formulation 2) (Drug)
NPT 2042 80mg (Test Formulation) in Fasted State with co-administered agent
NPT 2042 80mgSingle-dose, test formulation, given in fasted state with co-administered agent.
干预措施: NPT 2042 (Test formula/Formulation 2) (Drug)
结局指标
主要结局
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
时间窗: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
Plasma NPT 2042 PK endpoints including the CL/F (NPT 2042 only).
To calculate the Frel and 90% confidence intervals for Formulation 1 (Reference) vs Formulation 2 (Test) both administered in a fasted state.
时间窗: Baseline (Day -1) as compared to Tx. period 1 (Day 1) and Tx. Period 2 (Day 4)
The Frel calculations will be based on Cmax and AUCinf values for NPT 2042.
次要结局
未报告次要终点