NCT07446881已完成1 期
A Phase 1, Randomized, Controlled, Latin-square, Open-label Study, to Evaluate the Effect of ADV7103 on Gastric pH Under Fed and Fasting Conditions in Adult Healthy Participants
Advicenne Pharma1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年2月25日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The effect of a single dose of ADV7103 on gastric pH under fasting and fed conditions in adult healthy participants.
研究概览
简要总结
This was a Phase 1, single-center, randomized, controlled, Latin-square, open-label study to evaluate the effect of ADV7103 on the gastric pH, after administering a single oral dose of ADV7103 in healthy adult participants under fasting and fed conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Healthy male or female, who were aged 18-45 years (inclusive) on the day of signing the informed consent form (ICF).
- •4. Had a body weight between 50.0-100.0 kg (inclusive) at screening and D-
- •Had a body mass index (BMI) between 18.0-30.0 kg/m2 (inclusive) at screening and D-
- •Participants had vital signs results within normal ranges at screening and D-
- •If outside normal ranges, the values were considered by the Investigator without clinically significant abnormal findings.
- •Had physical examination results without clinically significant abnormal findings confirmed by the Investigator at screening and D-
- •Had clinical laboratory test results (hematology, coagulation, blood chemistry and urinalysis) within normal ranges at screening. If outside of normal ranges, the values were considered by the Investigator as not clinically significant, without abnormal findings.
- •9. Had 12-lead ECG results without clinically significant abnormal findings confirmed by the Investigator at screening.
- •Female participants who were not pregnant confirmed by beta-human chorionic gonadotropin (β-HCG) or nursing at screening and D-1, or who were not planning to become pregnant during study period.
- •11. Female participants of non-childbearing potential, defined as one of the following:
- •At least 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., appropriate age) and follicle-stimulating hormone (FSH) in the range for menopausal female confirmed by blood test according to current local standards at screening, except if treated with hormone replacement therapy (HRT]).
- •Those with history of hysterectomy or surgical removal of both ovaries or bilateral tubal ligation performed at least 90 days prior to screening.
- •12. Female participants of childbearing potential (WOCBP) agreed to use an adequate and highly effective method of contraception (according to Clinical Trials Coordination Group [CTCG] recommendations) starting at screening and throughout the entire study: a) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, started at least 4 weeks prior to the dosing (D1) and use of condom for the male partner.
- •b) Progestogen-only hormonal contraception associated with inhibition of ovulation, started at least 4 weeks prior to the dosing (D1) and use of condom for the male partner.
- •c) Intrauterine device (IUD) placed at least 4 weeks prior to the dosing (D1), and use of condom for the male partner.
- •d) Intrauterine hormone-releasing system (IUS) placed at least 4 weeks prior to the dosing (D1), and use of condom for the male partner.
- •e) Simultaneous use of a diaphragm or cervical cap with intravaginally applied spermicide and, for the male partner, a male condom. f) Sterile male partner, i.e., vasectomized since at least 3 months before inclusion.
- •Sexual abstinence[4] (when in line with the preferred and usual participant's lifestyle). Note: Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception.
- •Male participants were either surgically sterile (> 90 days since vasectomy), or abstinent as a usual practice, or if engaged in sexual relations with a WOCBP, the participant and his partner were either surgically sterile or used an acceptable, highly effective contraceptive method according to CTCG recommendations starting at screening and throughout the entire study.
- •14. Male participants agreed to abstain from sperm donation starting at screening and throughout the trial. Regulations
- •Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
- •16. Was competent in speaking, writing, and comprehending the local language(s) where the study is conducted.
排除标准
- •Had a history of and/or current clinically significant, determined by the Investigator, gastrointestinal, renal, hepatic, cardiovascular, hematological, respiratory, neurologic, metabolic, psychiatric, infectious disorder, drug or alcohol abuse, or allergic disease, hypersensitivity, or allergic reactions excluding mild asymptomatic seasonal allergies (either spontaneous or following drug administration).
- •2. Had a history of malignancy (including lymphoma, leukemia, and skin cancer) unless remission at least 10 years prior to screening.
- •3. Had a history of metabolic alkalosis or hyperkalemia.
- •Had urinary infection.
- •Had a history of difficult access to the oral administration route and/or conditions that could have hampered compliance and/or absorption of the IMPs, and/or the use and/or the proper functioning of the pH probe (e.g., gastroesophageal reflux, gastrectomy, bariatric surgery).
- •6. Had a personal or family history of prolonged QT interval syndrome or Torsade de Pointes, or family history of sudden death.
- •7. Had surgery (including invasive dental treatment or dental surgery) within one month or considered clinically significant by the Investigator, prior to D1, and/or planned to have surgery over the course of the study.
- •8. Had a history and/or current presence of an illness within 14 days prior to D1 that was categorized as clinically significant by the Investigator. Had history or presence of regular use of recreational drugs within 1 year before screening.
- •Donated blood or had blood loss (i.e., > 450 mL) within 1 month before screening.
- •11. Had known allergies, hypersensitivity or intolerance to IMP, or excipients present in drug product.
- •Physical and Laboratory Findings
- •Individualized estimated glomerular filtration rate (eGFR): [(standard CKD-EPI÷1.73)×BSA] <90 mL/min. at screening.
- •Had a positive pregnancy test for female participants.
- •Had a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab) at screening.
- •15. Had positive findings of urine drug screen (methadone, barbiturates, morphine, amphetamines, methamphetamines, opiates, cannabinoids, cocaine, benzodiazepines, tricyclic antidepressants (TCA), 3,4-methylenedioxy-methamphetamine [MDMA; ecstasy]) at screening or D-
- •16. Had a positive alcohol breath test result at screening or D-
- •Lifestyle Restrictions
- •Consumed any xanthine-containing products (e.g., coffee, tea, chocolate, or Coca-Cola like drinks) more than 6 cups per day (or equivalent), or alcoholic beverages within 24h before study D
- •18. Had regular consumption of alcoholic beverages that exceeded 21 units per week (1 unit = 12 g of pure alcohol) for males and 14 units per week for females.
- •19. Consumed nicotine daily (i.e., ≥10 cigarettes, vaping or chewing tobacco, nicotine patch or gum), or was unable to stop, from screening to the end of the hospitalization period or had substantial changes in nicotine consumption in the 4 weeks prior to screening. Prior/Concurrent Clinical Study Experience
- •Participants who had participated in another clinical study and were in the exclusion period or were participating in or intended to participate in another clinical study of an investigational drug before completion of all scheduled evaluations in this clinical study.
- •Prohibited Treatments
- •Used any prescription drugs within 2 weeks prior to first dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, St. John's wort, dietary supplements) within 5 days prior to first dosing (14 days for compounds with a half-life longer than 24h). Paracetamol (acetaminophen) was acceptable, if allowed by the Investigator, up to 2 intakes of 1000 mg per day. Prescribed hormonal contraception for WOCBP and HRT for post-menopausal women was also acceptable. Other Exclusions
- •Participants who, in the opinion of the Investigator, were not likely to complete the study for whatever reason.
研究组 & 干预措施
ADV7103
Experimental
open label single group phase 1
干预措施: ADV7103 (Drug)
结局指标
主要结局
The effect of a single dose of ADV7103 on gastric pH under fasting and fed conditions in adult healthy participants.
时间窗: 4 days
次要结局
未报告次要终点
研究者
研究点 (1)
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