NCT06842134已完成1 期
Phase 1, Prospective, Single-Center, Randomized Sequence, Open Label, 2-Way Crossover Study Comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E.
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Baseline-corrected maximum observed concentration (C(maxbc)) for inorganic phosphate
研究概览
简要总结
This is a phase 1, prospective, single-center, randomized sequence, open label, 2-way crossover study comparing Organic Phosphate (Sodium Glycerophosphate Injection) to Numeta G16%E.
It is planned to randomize approximately 16 healthy male and female subjects. All study periods will be completed during a single residency, the overall duration of residency will be 11 days (10 nights).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Healthy males or non-pregnant, non-lactating healthy females.
- •Aged 18 to 55 years, inclusive, at the time of signing informed consent.
- •Body mass index (BMI) of 18.5 to 29.9 kg/m^2 and a minimum body weight of 57 kg as measured at screening.
- •Must be willing and able to comply with all study requirements including dietary requirements.
- •Subject must be literate, has signed a written informed consent form (ICF) and has the ability to communicate and comply with all study requirements
- •Must agree to use an adequate method of contraception.
- •Alkaline phosphatase level within standard reference range/normal limits at screening and admission.
- •Serum inorganic phosphate level within standard reference range/normal limits at screening and admission.
- •Serum parathyroid hormone (PTH) level within standard reference range/normal limits at screening.
- •Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within reference range/normal limits at screening and admission.
排除标准
- •Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 5 half-lives or within 30 days prior to first dose, whichever is longer.
- •Subjects who are study site or Sponsor employees, or subjects who are immediate family members of study site or Sponsor employees.
- •Subjects who have previously been administered IMP in this study.
- •History of any drug or alcohol abuse in the past 2 years prior to screening.
- •Regular alcohol consumption in 6 months prior to screening.
- •A confirmed positive alcohol urine test at screening or admission.
- •Current smokers or those who have smoked within the last 12 months prior to screening. A confirmed positive urine cotinine test at screening or first admission.
- •Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months prior to screening.
- •Females of childbearing potential must have a negative pregnancy test (urine pregnancy test at screening). Females who are pregnant or lactating will be excluded.
- •Have poor venous access that limits phlebotomy.
- •Clinically significant abnormal clinical chemistry or hematology as judged by the Investigator.
- •Clinically significant abnormal urinalysis as judged by the Investigator.
- •History of diabetes mellitus (types I or II).
- •Prediabetes (fasting blood sugar level of >106 (repeat x 1 for confirmation of abnormal level).
- •Hypertriglyceridemia (fasting triglyceride level of > 200 mg/dL) at screening.
- •Subjects who, in the Investigator's opinion, have a clinically significant abnormal 12-lead resting ECG.
- •Positive drugs of abuse test result.
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
- •Evidence of renal impairment at screening, as indicated by an eGFR < 90mL/min/m^
- •History of any active systemic or immunologic disease, including but not limited to active renal, hepatic, hematological, gastrointestinal (except appendectomies/cholecystectomy), endocrinal, pulmonary (including asthma), cardiovascular, neurologic, or neurological disease (including demyelinating diseases such as multiple sclerosis), hypertension, tuberculosis, or systemic fungal infection.
- •History of bleeding ulcer, bleeding abnormalities or coagulation abnormalities.
- •History of hypophosphatasia.
- •Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
- •Presence or history of clinically significant allergy requiring treatment, as judged by the Investigator. Hay fever is allowed unless it is active.
- •Significant serious active skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
- •Donation or loss of 1 pint of blood within 3 months, or donation of plasma within 7 days prior to first dose of study medication or had a transfusion of any blood product within 3 months prior to study drug administration.
- •Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g per day acetaminophen and HRT/hormonal contraception) within the last 30 days or five half-lives (whichever is longer), before IMP administration. Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as determined by the Investigator.
- •Subjects who have been administered a drug by depot injection within 30 days prior to the initial study drug administration or 6 half-lives of that drug, whichever is longer and at the discretion of the Investigator or who have received a recent (as determined by the Investigator) live or attenuated vaccination (with exception of a COVID-19 vaccine or flu vaccine), or exposure to communicable viral diseases such as chicken pox, varicella, and measles.
- •Failure to satisfy the Investigator of fitness to participate for any other reason.
- •Known hypersensitivity to egg, soya or peanut proteins.
- •Food allergies deemed clinically relevant by the investigator which would hinder ability to adhere to the prescribed diet.
研究组 & 干预措施
Sequence CD (Numeta G16%E/Organic phosphate)
Experimental
- Period 1: Regimen C (Numeta G16%E)
- Period 2: Regimen D (Organic phosphate (sodium glycerophosphate SGP))
干预措施: Numeta G16%E (Drug)
Sequence CD (Numeta G16%E/Organic phosphate)
Experimental
- Period 1: Regimen C (Numeta G16%E)
- Period 2: Regimen D (Organic phosphate (sodium glycerophosphate SGP))
干预措施: Sodium Glycerophosphate Injection (Drug)
Sequence DC (Organic phosphate/Numeta G16%E)
Experimental
- Period 1: Regimen D (Organic phosphate (sodium glycerophosphate SGP))
- Period 2: Regimen C (Numeta G16%E)
干预措施: Numeta G16%E (Drug)
Sequence DC (Organic phosphate/Numeta G16%E)
Experimental
- Period 1: Regimen D (Organic phosphate (sodium glycerophosphate SGP))
- Period 2: Regimen C (Numeta G16%E)
干预措施: Sodium Glycerophosphate Injection (Drug)
结局指标
主要结局
Baseline-corrected maximum observed concentration (C(maxbc)) for inorganic phosphate
时间窗: Days 1, 2, 7, and 8
Serum PK parameter
Baseline-corrected area under the curve from time 0 to 24h post-dose (AUC(0-24bc)) for inorganic phosphate
时间窗: Days 1, 2, 7, and 8
Serum PK parameter
次要结局
- Baseline-corrected total urinary inorganic phosphate excreted in the urine (Ae(0-24bc))(Days 1 and 7)
- Time of maximum observed concentration (T(max)) for inorganic phosphate(Days 1, 2, 7, and 8)
- Apparent terminal elimination half-life (T(1/2 z)) for inorganic phosphate(Days 1, 2, 7, and 8)
- Area under the curve from time 0 to 24h post-dose (AUC(0-24)) for inorganic phosphate(Days 1, 2, 7, and 8)
- Elimination rate constant (K(z)) for inorganic phosphate(Days 1, 2, 7, and 8)
- Total urinary inorganic phosphate excreted in the urine (Ae(0-24))(Days 1 and 7)
- T(max) for glycerophosphate(Days 1, 2, 7, and 8)
- Maximum observed concentration (C(max)) for inorganic phosphate(Days 1, 2, 7, and 8)
- Baseline-corrected time of maximum observed concentration (T(maxbc)) for glycerophosphate(Days 1, 2, 7, and 8)
- Baseline-corrected elimination rate constant (K(zbc)) for glycerophosphate(Days 1, 2, 7, and 8)
- K(z) for glycerophosphate(Days 1, 2, 7, and 8)
- C(maxbc) for glycerophosphate(Days 1, 2, 7, and 8)
- Baseline-corrected apparent terminal elimination half-life (T(1/2 zbc)) for glycerophosphate(Days 1, 2, 7, and 8)
- T(1/2 z) for glycerophosphate(Days 1, 2, 7, and 8)
- C(max) for glycerophosphate(Days 1, 2, 7, and 8)
- AUC(0-24bc) for glycerophosphate(Days 1, 2, 7, and 8)
- AUC(0-24) for glycerophosphate(Days 1, 2, 7, and 8)
- T(maxbc) for glycerol(Days 1, 2, 7, and 8)
- T(max) for glycerol(Days 1, 2, 7, and 8)
- T(1/2 zbc) for glycerol(Days 1, 2, 7, and 8)
- T(1/2 z) for glycerol(Days 1, 2, 7, and 8)
- K(zbc) for glycerol(Days 1, 2, 7, and 8)
- K(z) for glycerol(Days 1, 2, 7, and 8)
- C(maxbc) for glycerol(Days 1, 2, 7, and 8)
- C(max) for glycerol(Days 1, 2, 7, and 8)
- AUC(0-24bc) for glycerol(Days 1, 2, 7, and 8)
- AUC(0-24) for glycerol(Days 1, 2, 7, and 8)
- Change from baseline in Alanine Aminotransferase (ALT)(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in Alkaline Phosphatase(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in Aspartate Aminotransferase (AST)(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in total bilirubin(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in direct bilirubin(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in eGFR(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in Blood Urea Nitrogen (BUN)(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in creatinine(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in calcium(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in phosphate(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in magnesium(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in potassium(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in sodium(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in respiratory rate(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in heart rate(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in temperature(Baseline, Day 1, Day 2, Day 7, Day 8)
- Change from baseline in blood pressure(Baseline, Day 1, Day 2, Day 7, Day 8)
- Number of subjects with any physical examination interpreted as abnormal(Baseline through Day 11)
- Number of subjects experiencing any clinically significant abnormality in ECGs(Baseline, Day 1, Day 2, Day 7, Day 8)
- Number of subjects experiencing adverse events(Baseline through Day 20)
研究者
研究点 (1)
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