NCT04318743已完成1 期
A Bridging Trial to Compare the Pharmacokinetics of Glepaglutide (ZP1848) After Single Subcutaneous Adminstration by Vial/Syringe and by Autoinjector in Healthy Subjects
适应症
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
- 85
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Variables
研究概览
简要总结
This is an open-label, randomized, single center, 2-treatment, 3-period, 3-sequence reference-replicated, crossover trial in healthy subjects to compare the PK of glepaglutide (ZP1848) after a single SC administration by vial/syringe and by autoinjector.
详细描述
A total of 72 subjects will be randomized in a 1:1:1 ratio to receive 10 mg glepaglutide SC via vial/syringe (Reference) twice or autoinjector (Test) in one of the 3 treatment sequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject).
- •Healthy male or female subject aged between 18 years and 54 years, both inclusive, at screening.
- •Body mass index (BMI) >20.0 kg/m2 and <29.9 kg/m2, both inclusive, at screening.
- •Willing to maintain a stable weight for the duration of the trial.
- •In overall good health according to age (medical history, physical examination, vital signs, and laboratory assessments), as judged by the Investigator at screening.
- •Able to comply with all trial procedures.
排除标准
- •Significant medical history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator.
- •Subject with a history of colon cancer or a history of other cancers within the last 5 years.
- •Clinically significant abnormality from physical examination, standard 12-lead ECG, or vital signs measurements as determined by the Investigator.
- •Clinically significant abnormality in hematology, clinical chemistry, or urinalysis as determined by the Investigator (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is acceptable).
- •History of significant hypersensitivity, intolerance, suspected hypersensitivity to glepaglutide or related products, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
- •Positive results for hepatitis B surface antigens (HbsAg), hepatitis C virus (HCV) antibodies and/or human immunodeficiency virus (HIV) 1 antigen or HIV 1/2 antibodies, at screening.
- •Receipt of blood products within 2 months prior to screening.
- •Donation of blood or significant blood loss from 8 weeks prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
- •Use of any prescription medications/products (other than oral, implantable, transdermal, injectable, or intrauterine hormonal contraceptives) within 14 days prior to screening, unless deemed acceptable by the Investigator.
- •Use of any nonprescription, over-the-counter medication/products, including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations, within 7 days prior to screening unless deemed acceptable by the Investigator. Up to 2 grams per day of acetaminophen is allowed at the discretion of the Investigator.
- •Use of any medications/products known to be strong inhibitors or strong inducers of cytochrome P450 3A enzyme, including St. John's wort, within 30 days prior to screening, unless deemed acceptable by the Investigator.
- •Have previously received the investigational product.
- •Receipt of any investigational product within 60 days prior to screening. Participation in more than 3 other drug studies in the 10 months prior to screening in the current trial.
- •Previous exposure to glucagon-like peptide-1 (GLP-1), GLP-2, or analogs thereof. Previous exposure to human growth hormone, somatostatin, dipeptidyl peptidase-4 inhibitors, or analogs thereof within 6 months prior to screening.
- •Have previously completed or withdrawn from this trial or any other trial investigating glepaglutide.
- •History of alcoholism or drug/chemical abuse within 2 years prior to screening.
- •Current alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL wine).
- •Positive urine drug screen (confirmed by repeat).
- •Use of tobacco, smoking cessation products, or products containing nicotine (including but not limited to cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine lozenges, or nicotine gum ) within 3 months prior to screening.
- •Poor peripheral venous access.
- •Positive qualitative serum pregnancy test (serum human chorionic gonadotropin) (female subjects only).
- •Female who is pregnant, breastfeeding, intends to become pregnant in the immediate future.
- •Female subject of childbearing potential who is sexually active without using adequate contraceptive methods (see Section 3.4.8) from 4 weeks prior to first admission to the clinical research center until 3 months after the last dose of trial product.*
- •Male subject, who is not surgically sterilized and sexually active with a female partner of childbearing potential, and who is not willing to use adequate contraceptive methods (see Section 3.4.8), from the first dosing until 3 months after the last dose of trial product.
- •Subjects whom, in the opinion of the Investigator, should not participate in this trial.
- •Employee of PRA or the Sponsor or otherwise dependent. * Participant is of nonchildbearing potential, if she is either surgically sterilized (ie, by tubal ligation or removal of ovaries), has undergone complete hysterectomy, or is in a menopausal state (ie, at least one year without menses and a serum follicle-stimulating hormone [FSH] >40 IU/L at screening).
研究组 & 干预措施
autoinjector - vial/syringe - vial/syringe
Experimental
Single dose of Glepaglutide 10 mg for each treatment sequence
干预措施: Glepaglutide (Drug)
vial/syringe - autoinjector - vial/syringe
Experimental
Single dose of Glepaglutide 10 mg for each treatment sequence
干预措施: Glepaglutide (Drug)
vial/syringe - vial/syringe - autoinjector
Experimental
Single dose of Glepaglutide 10 mg for each treatment sequence
干预措施: Glepaglutide (Drug)
结局指标
主要结局
Pharmacokinetic Variables
时间窗: from time zero to the last time point with a measurable concentration
AUC0-t = area under the plasma ZP1848total concentration-time curve (AUC)
次要结局
- Safety Variables(16 weeks)
研究者
研究点 (1)
Loading locations...
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