Healthy VolunteersPhase 1NCT02530710
A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single Doses of Q203 in Normal, Healthy, Male and Female Volunteers
A Phase 1 study testing Q203 in people with Healthy Volunteers, run by Qurient Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Q203
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand and sign an informed consent form.
- Healthy adult males and females of non-childbearing potential, ages 18 to 55 years, inclusive at the time of screening.
- Body mass index of 18 to 32 kg/m2, inclusive, and weighing at least 50 kg.
- 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.
- 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.
- Male subjects must not donate sperm during the study and for 30 days after study drug dosing.
Show all 13Show fewer
- Able to understand and comply with all of the study requirements.
- Able to swallow 8 tablets in succession.
- Willing to fast a minimum of 8 hours before check-in.
- Agree not to donate blood, plasma, platelets or any other blood components for 1 month after receiving study drug.
- Willing to abstain from alcohol use from 48 hours before check-in through the end of the study.
- Willing to forgo sunbathing and prolonged exposure to sunlight during the study period.
- Willing to forgo strenuous exercise during the study period.
Who cannot join
- Any known chronic systemic viral infection (including a positive serological test for HIV, HBsAg or HCAb that indicates infection).
- History of or current active tuberculosis (TB).
- Any systemic infection or other systemic illness, including persistent cough, respiratory, or flu-like symptoms, in the previous 30 days before screening.
- History of histoplasmosis, coccidioidomycosis, or similar opportunistic fungal infection.
- Vaccination in the previous 30 days before screening.
- History of, or clinically significant evidence of, bradycardia, syncope, or ECG abnormality or any other cardiovascular abnormality.
Show all 24Show fewer
- Resting heart rate (HR) during screening or baseline ECG fewer than 50 beats per minute (bpm).
- History of seizures.
- 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).
- Any history of abnormal pulmonary function (e.g., asthma or related respiratory illnesses).
- 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.
- Use of any prescription or over-the-counter (OTC) drug or herbal product within 14 days before dosing.
- 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.
- 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.
- Any prior exposure to Q203 or participation in another investigational drug study within the previous 30 days before screening.
- Any donation of blood, plasma, or platelets or significant loss of blood within 56 days before dosing.
- Laboratory results outside the normal range, if considered clinically significant by the PI or his designee.
- Hemoglobin concentration < LLN.
- Any condition that might interfere with the absorption of the study medications.
- History of hypersensitivity or idiosyncratic reaction to any of the products administered during the study.
- History of unexplained syncope or fainting from the collection of blood, i.e., autonomic dysfunction.
- History of hypotension, including orthostatic hypotension.
- Inability to understand verbal and/or written English.
- Subjects with glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Q203, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q203Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Q203 | Experimental | Q203 drug products (10mg and 100mg tablets) Receives: Drug: Q203 |
| Placebo | Placebo comparator | Placebo tablets (same excipients used in Q203 drug products) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed through adverse events, vital signs, ECG, laboratory results, and telemetry monitoring
Measured: 7 days post dose
Secondary outcomes (3)
Pharmacokinetic analysis: Area under the plasma concentration
Measured: 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
Measured: 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
Measured: predose and 1, 2, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 216 and 312 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qurient Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530710
- Sponsor's protocol ID
- Q203-TB-PI-US001
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2015
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02530710
- Acronym / sponsor ID
- Q203-TB-PI-US001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Qurient Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Q203 | Experimental | Drug: Q203Q203 drug products (10mg and 100mg tablets) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets (same excipients used in Q203 drug products) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Able to understand and sign an informed consent form.
- Healthy adult males and females of non-childbearing potential, ages 18 to 55 years, inclusive at the time of screening.
- Body mass index of 18 to 32 kg/m2, inclusive, and weighing at least 50 kg.
- 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.
- 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.
Key exclusion criteria (24 listed)
- Any known chronic systemic viral infection (including a positive serological test for HIV, HBsAg or HCAb that indicates infection).
- History of or current active tuberculosis (TB).
- Any systemic infection or other systemic illness, including persistent cough, respiratory, or flu-like symptoms, in the previous 30 days before screening.
- History of histoplasmosis, coccidioidomycosis, or similar opportunistic fungal infection.
- Vaccination in the previous 30 days before screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q203 | Drug | Q203 |
| Placebo | Drug | Placebo |
Primary outcome
Safety assessed through adverse events, vital signs, ECG, laboratory results, and telemetry monitoring
Time frame: 7 days post dose
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Q203 in people with Healthy Volunteers, run by Qurient Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed through adverse events, vital signs, ECG, laboratory results, and telemetry monitoring (time frame: 7 days post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.