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Trial record 2 of 3 for:    Q203

A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02858973
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Qurient Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 1, 2016
First Posted Date  ICMJE August 8, 2016
Last Update Posted Date May 14, 2018
Study Start Date  ICMJE August 2016
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring [ Time Frame: 16 days post dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • Pharmacokinetic analysis: Area under the curve [ Time Frame: 16 days post dose ]
  • Pharmacokinetic analysis: Maximum observed plasma drug concentration [ Time Frame: 16 days post dose ]
  • Pharmacokinetic analysis: Time of maximum observed concentration [ Time Frame: 16 days post dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers
Official Title  ICMJE A Phase 1B, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Q203 When Administered Orally to Healthy Adult Subjects
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Q203
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Q203
    Q203 tablets
    Intervention: Drug: Q203
  • Placebo Comparator: Placebo
    Placebo tablets
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2018)
47
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2016)
24
Actual Study Completion Date  ICMJE May 8, 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
  2. Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age, inclusive, at screening.

Exclusion Criteria:

  1. 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.
  2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
  3. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02858973
Other Study ID Numbers  ICMJE Q203-TB-PI-US002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Qurient Co., Ltd.
Study Sponsor  ICMJE Qurient Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Qurient Co., Ltd.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP