A Crossover Bioavailability Clinical Trial of Parenteral Pyronaridine and Artesunate
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Plasma level of Pyronaridine
研究概览
简要总结
The clinical trial is a Phase I monocentric clinical trial with a two-armed crossover design to evaluate the bioavailability of parenteral Pyronaridine and Artesunate.
Pyronaridine and Artesunate are antimalarial agents with a history of clinical use, and Artesunate has been used clinically in combination with other drugs also. The action of Artesunate is a rapid knock down of the parasites, after which, the drug is quickly cleared as it has a short systemic half-life. Pyronaridine is also rapidly effective in the short term but has a long blood half-life thus providing a more sustained schizonticidal effect.
12 study subjects will be included into the clinical trial after having signed the informed consent, being screened and judged to be eligible. 6 of them (group 1) will, on Day 0, be injected intravenously with 4 mg base/kg of Pyronaridine together with 4 mg/kg of Artesunate. The group 2 (the other 6 subjects) will on the same day (Day 0) be injected intramuscularly with the 4 mg base/kg of Pyronaridine together with 4 mg/kg of Artesunate (into separate sites) 8 weeks later group 1 will be injected intramuscularly with the same amount of Pyronaridine and Artesunate as on Day 0. Group 2 will also get the same amount as on Day 0 but this time the injection will be intravenously for group 2.
The primary objective is to assess the safety and tolerability by measuring (a) the proportion of subjects with adverse events (AEs) and serious adverse events (SAEs) throughout the study; (b) the proportion of subjects with solicited AEs 15 days after IMP injection; (c) the proportion of subjects with unsolicited AEs throughout the clinical trial. Further, the pharmacokinetics of both drugs will be determined.
详细描述
The clinical trial is a Phase I monocentric clinical trial with a two-armed crossover design to evaluate the bioavailability of parenteral Pyronaridine and Artesunate.
Pyronaridine and Artesunate are antimalarial agents with a history of clinical use, and Artesunate has been used clinically in combination with other drugs also. The action of Artesunate is a rapid knock down of the parasites, after which, the drug is quickly cleared as it has a short systemic half-life. Pyronaridine is also rapidly effective in the short term but has a long blood half-life thus providing a more sustained schizonticidal effect.
12 study subjects will be included into the clinical trial after having signed the informed consent, being screened and judged to be eligible. 6 of them (group 1) will, on Day 0, be injected intravenously with 4 mg base/kg of Pyronaridine together with 4 mg/kg of Artesunate. The group 2 (the other 6 subjects) will on the same day (Day 0) be injected intramuscularly with the 4 mg base/kg of Pyronaridine together with 4 mg/kg of Artesunate (into separate sites) 8 weeks later group 1 will be injected intramuscularly with the same amount of Pyronaridine and Artesunate as on Day 0. Group 2 will also get the same amount as on Day 0 but this time the injection will be intravenously for group 2.
The primary objective is to assess the safety and tolerability by measuring (a) the proportion of subjects with adverse events (AEs) and serious adverse events (SAEs) throughout the study; (b) the proportion of subjects with solicited AEs 15 days after IMP injection; (c) the proportion of subjects with unsolicited AEs throughout the clinical trial. Further, the pharmacokinetics of both drugs will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers aged 18-45 years with an asymptomatic Plasmodium falciparum infection.
- •Able and willing (in the investigator's opinion) to comply with all trial requirements.
- •General good health based on medical history and clinical examination.
- •Written informed consent.
- •Available to participate in follow-up for the duration of the trial (4 months in total).
- •Reachable by phone during the whole trial period.
- •Women only: Must agree to practice continuous effective contraception for the duration of the trial.
排除标准
- •Pregnancy, lactation, or intention to become pregnant during the trial.
- •Known HIV-, HBV- and HCV-infection.
研究组 & 干预措施
Artesunate-pyronaridine intravenous
干预措施: artesunate-pyronaridine (Drug)
Artesunate-pyronaridine intramuscular
干预措施: artesunate-pyronaridine (Drug)
结局指标
主要结局
Plasma level of Pyronaridine
时间窗: iwithin the two week post injection
Change in concentration of post IV/IM injection whole blood and plasma level of Pyronaridine will be summarized over time
Plasma level of Artesunate/dihydroartemisinin
时间窗: within the two week post injection
Change in concentration of post IV/IM injection plasma level of Artesunate/dihydroartemisinin will be summarized over time
Safety of injectable artesunate-pyronaridine
时间窗: within the two week post injection
To assess the safety and tolerability by measuring (a) the proportion of subjects with adverse events (AEs) and serious adverse events (SAEs) throughout the study; (b) the proportion of subjects with solicited AEs 15 days after IMP injection; (c) the proportion of subjects with unsolicited AEs throughout the clinical trial
次要结局
- Pyronaridine area under the curve(within the two week post injection)
- Artesunate/dihydroartemisinin area under the curve(within the two week post injection)
研究者
Prof. Ayola Akim ADEGNIKA
Professor
Centre de Recherche Médicale de Lambaréné