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A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single 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: NCT02530710
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Qurient Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 18, 2015
First Posted Date  ICMJE August 21, 2015
Last Update Posted Date December 6, 2016
Study Start Date  ICMJE August 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
Safety assessed through adverse events, vital signs, ECG, laboratory results, and telemetry monitoring [ Time Frame: 7 days post dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2015)
  • Pharmacokinetic analysis: Area under the plasma concentration [ Time Frame: predose and 1, 2, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 216 and 312 hours postdose ]
  • Pharmacokinetic analysis: Maximum observed plasma drug concentration [ Time Frame: predose and 1, 2, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 216 and 312 hours postdose ]
  • Pharmacokinetic analysis: Time of maximum observed concentration [ Time Frame: predose and 1, 2, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 216 and 312 hours postdose ]
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 Single Doses of Q203 in Normal, Healthy, Male and Female Volunteers
Official Title  ICMJE A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single Doses of Q203 in Normal, Healthy, Male and Female Volunteers
Brief Summary

Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and female volunteers. Subjects will be randomly assigned to 1 of 7 treatment cohorts (Cohorts 1 - 7) of 8 subjects each, to receive either Q203 or placebo (6 active treatment : 2 placebo) in a fasting state.

Dose escalation to the next cohort may be considered when at least 6 out of 8 subjects, in a cohort, completes all procedures and none of the subjects has a clinically significant adverse event (AE) that is being followed, or at the discretion of the PI if no drug-related serious adverse events (SAEs) have occurred.

A food effect cohort will be enrolled to test administration of Q203 in a fed state, at 100 mg dose level (this dose level may change based on PK analysis results). Subjects who received 100mg dose in a fasting state will return and receive the second dose, with food.

Subjects will be followed up for AEs, SAE or pregnancy for 30 days postdrug administration.

Detailed Description

Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and female volunteers. Subjects will be randomly assigned to 1 of 7 treatment cohorts (Cohorts 1 - 7) of 8 subjects each, to receive either Q203 or placebo in a fasting state. Every attempt will be made to include at least 2 females in each cohort, at least one of whom will be assigned to receive Q203.

Dose escalation to the next cohort may be considered when at least 6 out of 8 subjects, in a cohort, completes all procedures and none of the subjects has a clinically significant adverse event (AE) that is being followed, or at the discretion of the PI if no drug-related SAEs have occurred. A food effect cohort will be enrolled to test administration of Q203 in a fed state, at 100 mg dose level (this dose level may change based on PK analysis results). Subjects who received 100mg dose in a fasting state will return and receive the second dose, with food. In this cohort, all eight subjects will proceed to receive either Q203 or placebo in a six to two ratio (six active treatment : 2 placebo). Every attempt will be made to include at least 2 females in this cohort, at least one of whom will be assigned to receive Q203.

Subjects will be followed up for AEs, SAE or pregnancy for 30 days postdrug administration.

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 drug products (10mg and 100mg tablets)
    Intervention: Drug: Q203
  • Placebo Comparator: Placebo
    Placebo tablets (same excipients used in Q203 drug products)
    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: August 19, 2015)
56
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Able to understand and sign an informed consent form.
  2. Healthy adult males and females of non-childbearing potential, ages 18 to 55 years, inclusive at the time of screening.
  3. Body mass index of 18 to 32 kg/m2, inclusive, and weighing at least 50 kg.
  4. Female subjects must be of non-childbearing potential (postmenopause or surgical sterilization). Postmenopausal status will be confirmed by a follicle-stimulating hormone (FSH) test at screening.
  5. Male subjects must agree to use a condom with spermicide when engaging in sexual intercourse during the study period and for 30 days after study drug dosing, if they have not had a vasectomy at least 6 months before study start.
  6. Male subjects must not donate sperm during the study and for 30 days after study drug dosing.
  7. Able to understand and comply with all of the study requirements.
  8. Able to swallow 8 tablets in succession.
  9. Willing to fast a minimum of 8 hours before check-in.
  10. Agree not to donate blood, plasma, platelets or any other blood components for 1 month after receiving study drug.
  11. Willing to abstain from alcohol use from 48 hours before check-in through the end of the study.
  12. Willing to forgo sunbathing and prolonged exposure to sunlight during the study period.
  13. Willing to forgo strenuous exercise during the study period.

Exclusion Criteria:

  1. Any known chronic systemic viral infection (including a positive serological test for HIV, HBsAg or HCAb that indicates infection).
  2. History of or current active tuberculosis (TB).
  3. Any systemic infection or other systemic illness, including persistent cough, respiratory, or flu-like symptoms, in the previous 30 days before screening.
  4. History of histoplasmosis, coccidioidomycosis, or similar opportunistic fungal infection.
  5. Vaccination in the previous 30 days before screening.
  6. History of, or clinically significant evidence of, bradycardia, syncope, or ECG abnormality or any other cardiovascular abnormality.
  7. Resting heart rate (HR) during screening or baseline ECG fewer than 50 beats per minute (bpm).
  8. History of seizures.
  9. History of drug (including amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidines, and cannabinoids) or alcohol abuse or addiction within the past 2 years or, if male, consumes more than 28 units of alcohol per week or, if female, consumes more than 21 units of alcohol per week (1 unit of alcohol equals 250 mL of beer, 100 mL of wine, or 25 mL of spirits).
  10. Any history of abnormal pulmonary function (e.g., asthma or related respiratory illnesses).
  11. Current or recent (within the past 3 months) use of tobacco or other nicotine-containing product or positive results for nicotine testing at screening or check-in.
  12. Use of any prescription or over-the-counter (OTC) drug or herbal product within 14 days before dosing.
  13. Use of any known drug metabolism enzyme-altering drug (inducers or inhibitors) or supplement (e.g., St. John's wort) within 14 days before dosing or consumption of foods or beverages containing alcohol or grapefruit within 48 hours before dosing.
  14. Use of any QT-prolonging agents, including, but not limited to, azithromycin, bepridil chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide dofetilide, domperidone, droperidol, erythromycin, Halofantrine, haloperidol, ibutilide, levomethadyl, lumefantrine, mefloquine, mesoridazine, methadone, moxifloxacin, pentamidine, pimozide, procainamide, quinidine, quinine, roxithromycin, sotalol, sparfloxacin, terfenadine, or thioridazine, from within 28 days before dosing through end of study.
  15. Any prior exposure to Q203 or participation in another investigational drug study within the previous 30 days before screening.
  16. Any donation of blood, plasma, or platelets or significant loss of blood within 56 days before dosing.
  17. Laboratory results outside the normal range, if considered clinically significant by the PI or his designee.
  18. Hemoglobin concentration < LLN.
  19. Any condition that might interfere with the absorption of the study medications.
  20. History of hypersensitivity or idiosyncratic reaction to any of the products administered during the study.
  21. History of unexplained syncope or fainting from the collection of blood, i.e., autonomic dysfunction.
  22. History of hypotension, including orthostatic hypotension.
  23. Inability to understand verbal and/or written English.
  24. Subjects with glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 NCT02530710
Other Study ID Numbers  ICMJE Q203-TB-PI-US001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 August 2016

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