Crossover Study to Evaluate the Comparative Bioavailability, Pharmacokinetics, and Safety of GTX-102 Administered as an Oral Spray Compared to Intramuscular Injection and an Oral Solution of Betamethasone in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUC from 0 to 72 hours post-dose
研究概览
简要总结
A Randomized, Open-label, Crossover Study to Evaluate the Comparative Bioavailability, Pharmacokinetics, and Safety of GTX-102 Administered as an Oral Spray Compared to Intramuscular Injection - betamethasone and an Oral Solution of Betamethasone in Healthy Subjects.
Four groups of subjects will receive 2 treatments each and randomized in 2-way crossover.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects between the ages of 18 and 55 years, inclusive.
- •Willing and able to provide written informed consent prior to participating in the study.
- •Able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and understand study procedures.
- •Able to complete all screening period evaluations, and stay in the clinic testing facility for up to 2 consecutive days on 2 separate occasions.
- •Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and body weight between 40 and 120 kg, inclusive.
排除标准
- •Has a history of or current clinically significant medical illness including (but not limited to) pulmonary, cardiovascular, coagulation disorders, lipid abnormalities, gastrointestinal, immunologic, endocrine (stable thyroid hormone replacement therapy is not excluded), neurologic, psychiatric, or thromboembolic disease, metabolic disturbances, or any other current physical condition that the Investigator considers should exclude the participant, or that could interfere with the interpretation of the study results.
- •Has current or recent (within 6 months) history of gastrointestinal disease, or any surgical or medical condition such as Crohn's disease or liver disease, that could potentially alter the absorption, metabolism, or excretion of the study drug.
- •Has any clinically significant medical condition, physical examination finding, vital signs, ECG abnormality (at screening), or clinically significant abnormal value for hematology, serology, clinical chemistry, or urinalysis at screening or at admission to the study center, as deemed appropriate by the Investigator
研究组 & 干预措施
Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2
GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered fast or slow over two periods
干预措施: GTX-102 medium dose fast Period 1 and Period 2 (Drug)
Group 1 GTX-102 medium dose fast or slow in Period 1 and Period 2
GTX-102 Betamethasone oral spray medium dose (0.05 mg/kg) administered fast or slow over two periods
干预措施: GTX-102 medium dose slow Period 1 and Period 2 (Drug)
Group 2a GTX-102 high dose fast in Period 1 and Period 2
GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods
Note: Note under US IND
干预措施: GTX-102 high dose fast Period 1 and Period 2 (Drug)
Group 2b Oral comparator in Period 1 and Period 2
0.1 mg/kg betamethasone solution oral drops solution over two periods
Note: Not under US IND
干预措施: Betamethasone Oral Solution Period 1 and Period 2 (Drug)
Group 3 GTX-102 high dose fast or low dose fast in Period 1 and Period 2
GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) or GTX-102 Betamethasone oral spray low dose (0.025 mg/kg) administered fast over two periods
干预措施: GTX-102 high dose fast Period 1 and Period 2 (Drug)
Group 3 GTX-102 high dose fast or low dose fast in Period 1 and Period 2
GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) or GTX-102 Betamethasone oral spray low dose (0.025 mg/kg) administered fast over two periods
干预措施: GTX-102 low dose fast Period 1 and Period 2 (Drug)
Group 4a GTX-102 high dose fast in Period 1 and Period 2
GTX-102 Betamethasone oral spray high dose (0.1 mg/kg) administered fast over two periods
干预措施: GTX-102 high dose fast Period 1 and Period 2 (Drug)
Group 4b betamethasone intramuscular in Period 1 and Period 2
0.1 mg/kg betamethasone solution as intramuscular injection administered over two periods
干预措施: Betamethasone solution as intramuscular injection Period 1 and Period 2 (Drug)
结局指标
主要结局
AUC from 0 to 72 hours post-dose
时间窗: Up to 72 hours post-dose
Area under the curve
AUC
时间窗: Up to infinity
Area under the curve
Cmax from 0 to 72 hours post-dose
时间窗: Up to 72 hours post-dose
Maximum concentration
次要结局
- Adverse Events from Day 1 to Day 45(Day 1 to Day 45)
- Relative bioavailability of GTX-102 oral spray versus betamethasone oral solution and betamethasone intramuscular injection(Up to infinity)