A SINGLE CENTER, 5-PART, RANDOMIZED, DOUBLE-BLIND AND PLACEBO-CONTROLLED (Parts 1, 4, 5), OPEN-LABEL AND CROSSOVER (Parts 2, 3) STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING DOSES (Parts 1, 4), AND SINGLE DOSES (Parts 2, 3, 5), OF GAL-101 SALT IN HEALTHY ADULT AND ELDERLY PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events
研究概览
简要总结
This first-in-human Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of GAL-101 salt following oral administration to healthy adult and elderly participants. A total of 92 participants were enrolled at a single study center.
The study consisted of five parts. Part 1 evaluated single ascending doses of enteric-coated GAL-101 capsules compared with placebo in healthy adults. Part 2 compared a single dose of enteric-coated GAL-101 capsules with uncoated GAL-101 salt mixed with apple sauce in an open-label crossover design. Part 3 evaluated the effect of fasting, a standard meal, and a high-fat, high-calorie meal on the pharmacokinetics of a single dose of uncoated GAL-101 salt in an open-label crossover design. Part 4 evaluated multiple ascending doses of uncoated GAL-101 salt administered once daily for 7 days compared with placebo. Part 5 evaluated the pharmacokinetics of a single dose of uncoated GAL-101 salt compared with placebo in healthy elderly participants aged 65 to 85 years.
详细描述
GAL-101 as eye drops was previously evaluated in a Phase 1 study in healthy volunteers and Glaucoma (ClinicalTrials.gov Identifier: NCT01714960).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female participants, as determined by medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory assessments.
- •Aged years 18-60 for Parts 1-4 and 65-85 years for Part
- •Body mass index between 18.5 and 30 kg/m².
- •Able and willing to provide written informed consent.
- •Willing to comply with contraception requirements, where applicable.
排除标准
- •Clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, respiratory, hematological, or metabolic disease.
- •Clinically significant abnormal laboratory, vital-sign, physical-examination, or electrocardiogram findings.
- •Known hypersensitivity to GAL-101, related compounds, or formulation components.
- •Use of prohibited prescription or nonprescription medication within the protocol-specified period.
- •Positive testing for drugs of abuse, alcohol, or relevant infectious diseases.
- •History of significant alcohol or substance misuse.
- •Participation in another clinical study or receipt of another investigational product within the protocol-specified period.
- •Blood donation or significant blood loss within the protocol-specified period.
- •Pregnant or breastfeeding.
- •Any condition that, in the investigator's opinion, could affect participant safety or study-result interpretation.
研究组 & 干预措施
Part 1: GAL-101 195 mg
Healthy adult participants received a single oral dose of 195 mg GAL-101 salt as one enteric-coated capsule under fasting conditions on Day 1.
干预措施: Enteric-Coated Capsules 195 mg (Drug)
Part 1: Placebo-195 mg Cohort
Healthy adult participants received matching placebo corresponding to the 195 mg cohort under fasting conditions on Day 1.
干预措施: Placebo (Drug)
Part 1: GAL-101 390 mg
Healthy adult participants received a single oral dose of 390 mg GAL-101 salt as two enteric-coated capsules under fasting conditions on Day 1.
干预措施: Enteric-Coated Capsules 390 mg (Drug)
Part 1: Placebo-390 mg Cohort
Healthy adult participants received a single oral dose of 390 mg GAL-101 salt as two enteric-coated capsules under fasting conditions on Day 1.
干预措施: Placebo (Drug)
Part 1: GAL-101 780 mg
Healthy adult participants received a single oral dose of 780 mg GAL-101 salt as four enteric-coated capsules under fasting conditions on Day 1.
干预措施: Enteric-Coated Capsules 780 mg (Drug)
Part 1: Placebo-780 mg Cohort
Healthy adult participants received a single oral dose of 780 mg GAL-101 salt as four enteric-coated capsules under fasting conditions on Day 1.
干预措施: Placebo (Drug)
Part 1: GAL-101 1170 mg
Healthy adult participants received a single oral dose of 1170 mg GAL-101 salt as six enteric-coated capsules under fasting conditions on Day 1.
干预措施: Enteric-Coated Capsules 1170 mg (Drug)
Part 1: Placebo-1170 mg Cohort
Healthy adult participants received a single oral dose of 1170 mg GAL-101 salt as six enteric-coated capsules under fasting conditions on Day 1.
干预措施: Placebo (Drug)
Part 1: Placebo-1755 mg Cohort
Healthy adult participants received a single oral dose of 1755 mg GAL-101 salt as nine enteric-coated capsules under fasting conditions on Day 1.
干预措施: Placebo (Drug)
Part 2: Enteric-coated/Uncoated Sequence
Participants received a single 1170 mg dose of GAL-101 salt as enteric-coated capsules in Period 1, followed by a single 1170 mg dose as uncoated GAL-101 salt mixed with apple sauce in Period 2. Both treatments were administered under fasting conditions, with a washout of at least 7 days.
干预措施: Enteric-Coated Capsules 1170 mg (Drug)
Part 2: Uncoated/Enteric-coated Sequence
Participants received a single 1170 mg dose of uncoated GAL-101 salt mixed with apple sauce in Period 1, followed by a single 1170 mg dose as enteric-coated capsules in Period 2. Both treatments were administered under fasting conditions, with a washout of at least 7 days.
干预措施: Uncoated GAL-101 Salt 1170 mg (Drug)
Part 2: Uncoated/Enteric-coated Sequence
Participants received a single 1170 mg dose of uncoated GAL-101 salt mixed with apple sauce in Period 1, followed by a single 1170 mg dose as enteric-coated capsules in Period 2. Both treatments were administered under fasting conditions, with a washout of at least 7 days.
干预措施: Enteric-Coated Capsules 1170 mg (Drug)
Part 3: Food-effect Sequence 1
Participants received three single 1170 mg doses of uncoated GAL-101 salt mixed with apple sauce according to Sequence 1: under fasting conditions, after a standard meal, and after a high-fat, high-calorie meal, with a washout of at least 7 days between periods.
干预措施: Enteric-Coated Capsules 1170 mg (Drug)
Part 3: Food-effect Sequence 2
Participants received three single 1170 mg doses of uncoated GAL-101 salt mixed with apple sauce according to Sequence 2: under fasting conditions, after a standard meal, and after a high-fat, high-calorie meal, with a washout of at least 7 days between periods.
干预措施: Enteric-Coated Capsules 1170 mg (Drug)
Part 4: GAL-101 780 mg Once Daily
Healthy adult participants received 780 mg uncoated GAL-101 salt mixed with apple sauce orally once daily under fasting conditions for 7 days.
干预措施: Uncoated GAL-101 Salt 780 mg (Drug)
Part 4: Placebo-780 mg Cohort
Healthy adult participants received matching placebo orally once daily under fasting conditions for 7 days in the 780 mg cohort.
干预措施: Placebo (Drug)
Part 4: GAL-101 1170 mg Once Daily
Healthy adult participants received 1170 mg uncoated GAL-101 salt mixed with apple sauce orally once daily under fasting conditions for 7 days.
干预措施: Uncoated GAL-101 Salt 1170 mg (Drug)
Part 4: Placebo-1170 mg Cohort
Healthy elderly participants aged 65-85 years received a single oral dose of 1170 mg uncoated GAL-101 salt mixed with apple sauce under fasting conditions on Day 1.
干预措施: Placebo (Drug)
Part 4: Placebo-1170 mg Cohort
Healthy elderly participants aged 65-85 years received a single oral dose of 1170 mg uncoated GAL-101 salt mixed with apple sauce under fasting conditions on Day 1.
干预措施: Enteric-Coated Capsules 1170 mg (Drug)
Part 5: GAL-101 1170 mg-Elderly
Healthy elderly participants aged 65-85 years received a single oral dose of 1170 mg uncoated GAL-101 salt mixed with apple sauce under fasting conditions on Day 1.
干预措施: Enteric-Coated Capsules 1170 mg (Drug)
Part 1: GAL-101 1755 mg
Healthy adult participants received a single oral dose of 1755 mg GAL-101 salt as nine enteric-coated capsules under fasting conditions on Day 1.
干预措施: Enteric-Coated Capsules 1755 mg (Drug)
Part 5: Placebo-Elderly
Healthy elderly participants aged 65-85 years received a single oral dose of 1170 mg uncoated GAL-101 salt mixed with apple sauce under fasting conditions on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events
时间窗: From the first dose through 28 days after the participant's last dose
Treatment-emergent adverse events, serious adverse events, adverse events of special interest, and dose-limiting toxicities were assessed after administration of GAL-101 salt or placebo. Events were evaluated by severity and relationship to the study intervention.
次要结局
未报告次要终点