Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 in Healthy Subjects
Study Details
Study Description
Brief Summary
Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
A Dose-randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose, Dose-escalation, Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: JP-2266 Drug: JP-2266 |
Drug: JP-2266
Single Ascending Dose: Single administration on Day 1
Food effect cohort: Single administration on Day 1 of each period
Multiple Ascending Dose: Repeated administrations from D1 to D15
|
Placebo Comparator: JP-2266 Placebo Drug: JP-2266 Placebo |
Drug: JP-2266 Placebo
Single Ascending Dose: Single administration on Day 1
Food effect cohort: Single administration on Day 1 of each period
Multiple Ascending Dose: Repeated administrations from D1 to D15
|
Outcome Measures
Primary Outcome Measures
- The evaluation of the number of adverse events and the number and percentage of subjects [up to Day 10]
Single Ascending Dose
- Assessment of PK parameter: Maximum plasma concentration (Cmax) [up to 72hours of each period]
Food effect cohort
- The evaluation of the number of adverse events and the number and percentage of subjects [up to Day 19]
Multiple Ascending Dose
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy male Caucasian subject aged 18 to 50 years inclusive
-
Body Mass Index (BMI) between 18 and 27 kg/m2 inclusive and body weight ≥ 50 kg at screening
-
Signing a written informed consent prior to selection;
Exclusion Criteria:
- Any history (including family history) or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease;
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | OPTIMED clinical research | Gières | France | 38610 |
Sponsors and Collaborators
- Jeil Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JP-2266-101-FIH