A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers
- Registration Number
- NCT02858973
- Lead Sponsor
- Qurient Co., Ltd.
- Brief Summary
This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203 in healthy volunteers conducted at one study center in the United States
- Detailed Description
Six (6) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive multiple oral doses of Q203 or placebo for 14 days QD with a standard meal. Subjects will participate in only one cohort.
Safety (i.e., physical examinations, vital signs, ECGs, clinical laboratory tests, and adverse events \[AEs\]) will be assessed throughout the study; serial blood and urine samples will be collected for these assessments. Blood samples will also be collected for the PK assessment of Q203.
Escalation to the next dose level (i.e., initiation of the next cohort) will not take place until the Principal Investigator (PI), medical monitor, and representatives of the Sponsor have reviewed all available safety and tolerability from the previous cohorts and agree to the initiation of the next cohort.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
- Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening.
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo tablets Q203 Q203 Q203 tablets
- Primary Outcome Measures
Name Time Method Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring 16 days post dose
- Secondary Outcome Measures
Name Time Method Pharmacokinetic analysis: Area under the curve 16 days post dose Pharmacokinetic analysis: Maximum observed plasma drug concentration 16 days post dose Pharmacokinetic analysis: Time of maximum observed concentration 16 days post dose