EpilepsyPhase 1NCT01918735
A Study of the Safety and Tolerability of GWP42006 in Healthy Subjects
A Phase 1 study testing GWP42006 in people with Epilepsy, run by Jazz Pharmaceuticals at 1 site in United Kingdom.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of single ascending (increasing) and multiple doses of GWP42006 compared with placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- GWP42006
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Dec 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy females of non-childbearing potential or healthy males
- Age 18 to 65 years, inclusive
- Body mass index of 18 to 30 kg/m2 inclusive or, if outside the range, considered not clinically significant by the investigator
- Must have no clinically significant abnormal findings on physical examination, vital signs, electrocardiogram, medical history, or clinical laboratory results during screening or Day -1 (admission)
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
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- Must be willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study
- Must agree to use an adequate method of contraception: Two or more of the following methods are acceptable and must include at least one barrier method:
- Surgical sterilisation (i.e. bilateral tubal ligation, hysterectomy for female partners; vasectomy for males)
- Placement of an intrauterine device or intrauterine system
- Hormonal contraception (implantable, patch, oral)
- Barrier methods (for male subjects, this must be a condom; for female subjects, either their partner's use of a condom or the subject's use of an occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository).
- Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle.
Who cannot join
- Participation in a clinical research study/receiving an Investigational Medicinal Product within the 3 months prior to screening
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been randomised in this study
- History of any drug or alcohol abuse in the past 2 years, or current habituation to any medications or illegal drugs
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = 0.5 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Tobacco product use in the previous 6 months. A breath carbon monoxide reading of greater than 10 ppm at screening
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- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator
- Positive drugs of abuse test result
- Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus-1 and -2 results
- History of clinically relevant physical abnormalities, medical conditions or clinical laboratory test results e.g. cardiovascular, renal, hepatic, pulmonary, haematological, endocrinological, neurological, psychiatric, chronic respiratory or gastrointestinal disease as judged by the investigator
- Clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening
- Known cardiovascular condition or history of a cardiovascular condition or clinically relevant abnormalities in the 12-lead electrocardiogram measured at screening
- Subject has a postural drop of 20 mmHg or more in systolic blood pressure at screening, with features of postural hypotension, in the opinion of the investigator
- Concurrent cardiovascular conditions, which will, in the investigators opinion, interfere with the ability to read their electrocardiograms
- Current use or past use of recreational or medicinal cannabis, or cannabinoid based medications (including Sativex) within the 3 months prior to study entry and is unwilling to abstain for the duration for the study
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients (e.g. cannabinoids, sesame oil)
- Presence or history of clinically significant allergy requiring treatment as judged by the investigator. Hayfever is allowed unless it is active
- Donation or loss of greater than 500 mL of blood within the previous 3 months
- Unwilling to abstain from donation of blood during the planned study
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol and hormone replacement therapy) or herbal remedies in the 14 days before Investigational Medicinal Product administration
- Travel outside the country of residence planned during the study
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Dose Escalation, Safety, Tolerability and Pharmacokinetics Study of Single Ascending and Multiple Doses of GWP42006 in Healthy Volunteers
The primary objective of this study is to evaluate the safety and tolerability of single ascending (increasing) and multiple doses of GWP42006 compared with placebo.
Read the detailed description
This is a single-centre, randomised, double-blind, placebo-controlled, parallel group dose escalation, safety, tolerability and pharmacokinetic (PK) study of single escalating and multiple doses of GWP42006 in healthy volunteers. The study consists of 5 single dosing occasions, and a five day repeated dose period.
Part 1 Single Dosing:
Four parallel groups of 11 subjects will participate in the oral single dosing, dose escalation study phase. In each group, subjects will be randomly assigned so that eight subjects receive active and three subjects receive placebo. It is planned for Groups 1 and 2, that a staggered 'sentinel' dose design will be used, with two sub-groups:
- The first will comprise of one placebo and one active subject.
- In the second, seven subjects will receive active and two will receive placebo after a review of the 24 h post-dose safety data of the first group.
Sentinel subject dosing will be performed in higher-dose groups if there is no measurable plasma GWP42006 in Group 1 or 2.
One group within the single dosing part (Group 3/dose level 3) will then receive an intravenous administration of 5 mg GWP42006 to allow assessment of bioavailability. There will be a minimum of seven days between doses.
Up to three further groups may be added for further evaluations, e.g. to assess additional dose levels or food effect. The need for additional groups will be based on a review of the safety, tolerability and PK data by the safety advisory committee.
Dose Escalation:
The planned dose levels are 25 mg (Group 1/dose level 1), 75 mg (Group 2/dose level 2), 200 mg (Group 3/dose level 3) and 400 mg (Group 4/dose level 4), with a maximum dose of 800 mg. Administration of each successive dose will be dependent on safety, tolerability and PK data of previous doses.
Part 2 Multiple Dosing:
The doses and dose regimens assessed in Part 2 will be selected based upon the safety, and PK data from Part 1 of the study.
It is planned that one group of 11 subjects will participate in the multiple dose phase, and subjects will be randomly assigned so that eight subjects receive active and three receive matching placebo. Each subject will receive the selected dose of GWP42006 or placebo once, twice or three times daily for a total of five days, with the final dose administered on the morning of Day 5.
Up to two further groups may be added for further evaluations, e.g. to assess a different dose level or a different dosing frequency. As for single dosing, the decision to include further groups will be taken based on safety, tolerability and PK data. All further groups would be added on blinded information.
- Conditions
- Epilepsy
- Being tested
- Placebo, GWP42006
- Keywords
- Safety, Tolerability, Assessment of potential adverse events, Assessment of potential laboratory abnormalities
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Placebo control
Placebo control matched to the oral or intravenous experimental comparator drug
GWP42006Drug
Oral administration of 25 (Group/dose level 1a and 1b), 75 (Group/dose level 2a and 2b), 200 (Group/dose level 3a and 3b) and 400 mg GWP42006 (Group/dose level 4a and 4b), provided as 50 mg/mL GWP42006 solution in sesame oil containing flavourings and sweetener, for dilution on the day of dosing, as required.
Additional intravenous administration of 5 mg GWP42006 and 10 mL Solutol HS 15 solution to Group/dose level 3a and 3b subjects.
| Study group | Role | What they receive |
|---|---|---|
| Group/dose level 1a | Experimental | 25 mg GWP42006 oral solution. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. Receives: Drug: GWP42006 |
| Group/dose level 1b | Placebo comparator | Matching placebo for Group/dose level 1a. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. Receives: Drug: Placebo |
| Group/dose level 2a | Experimental | 75 mg GWP42006 oral solution. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. Receives: Drug: GWP42006 |
| Group/dose level 2b | Placebo comparator | Matching placebo for Group/dose level 2a. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. Receives: Drug: Placebo |
| Group/dose level 3a | Experimental | 200 mg GWP42006 oral solution (single dose) followed by an intravenous administration of 5 mg GWP42006 after the oral dose Receives: Drug: GWP42006 |
| Group/dose level 3b | Placebo comparator | Matching placebo for Group/dose level 3a Receives: Drug: Placebo |
| Group/dose level 4a | Experimental | 400 mg GWP42006 oral solution Receives: Drug: GWP42006 |
| Group/dose level 4b | Placebo comparator | Matching placebo for Group/dose level 4a Receives: Drug: Placebo |
| GWP42006 1, 2, or 3 times daily | Experimental | Subjects will receive the selected dose of GWP42006 once, twice or three times daily (the number of daily doses and actual dose will be decided upon based on results from Part 1 of the study) for a total of 5 days, with the final dose given on the morning of Day 5. Receives: Drug: GWP42006 |
| Placebo 1, 2, or 3 times daily | Placebo comparator | Subjects will receive placebo once, twice or three times daily (the number of daily doses and actual dose will be decided upon based on results from Part 1 of the study) for a total of 5 days, with the final dose given on the morning of Day 5. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events as measure of subject safety
The number of subjects who experienced an adverse event during each arm of the study is presented.
Measured: Day 0 - Day 10
Secondary outcomes (3)
To determine the plasma concentration time curves for GWP42006, 7-hydroxy-GWP42006 and 6-hydroxy-GWP42006 compounds, following escalating single doses and multiple doses of pure GWP42006.
- For oral dosing, the pre-dose blood sample was taken ≤1 h before dosing.
- For intravenous dosing, the pre-dose sample was taken immediately before the intravenous bolus infusion.
- 0 to 1 h post-dose samples were taken within ± 2 min of the nominal post-dose sampling time (the 0.04 and 0.08 h pharmacokinetic samples taken post-intravenous dosing only were taken at the middle and the end of the intravenous bolus infusion).
- >1 to 12 h post-dose samples were taken within ± 10 min of the nominal post-dose sampling time.
- >12 h post-dose samples were taken within ± 30 min of the nominal post-dose sampling time if subjects were resident in the clinic.
The following pharmacokinetic parameters were investigated: Tmax, Area Under the plasma concentration Curve (AUC)(0-inf), AUC(0-t), T1/2el, F, AUC(0-tau) and Kel.
Measured: Pre-dose then 0, 0.04, 0.08, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 h post-dose
To investigate cognitive function following single ascending and multiples doses of GWP42006
A cognitive assessment was carried using the Fepsy battery. The following tests were carried out: auditory reaction times (left and right), recognition simultaneously (6 words, 4 figures), visual reaction task (white square, left and right), computerised visual searching task (24 small figures), finger tapping task, recognition serially (6 words, 4 figures) and binary choice task (random).
Measured: Admission (Day -1) and 2 h post-dose
To investigate gene expression following multiple doses of GWP42006
Analysis of gene expression was carried out for subjects participating in the multiple dose phase of the study.
Measured: Pre-dose on multiple dose Days 1-4 then 2 h post-dose on multiple dose Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918735
- Sponsor's protocol ID
- GWEP1303
- Status last verified
- Dec 2022
- First submitted
- 1 Aug 2013
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Dose Escalation, Safety, Tolerability and Pharmacokinetics Study of Single Ascending and Multiple Doses of GWP42006 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01918735
- Acronym / sponsor ID
- GWEP1303
- Conditions
- Epilepsy
- Keywords
- Safety, Tolerability, Assessment of potential adverse events, Assessment of potential laboratory abnormalities
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Aug 2013 (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.
The primary objective of this study is to evaluate the safety and tolerability of single ascending (increasing) and multiple doses of GWP42006 compared with placebo.
Detailed description
This is a single-centre, randomised, double-blind, placebo-controlled, parallel group dose escalation, safety, tolerability and pharmacokinetic (PK) study of single escalating and multiple doses of GWP42006 in healthy volunteers. The study consists of 5 single dosing occasions, and a five day repeated dose period.
Part 1 Single Dosing:
Four parallel groups of 11 subjects will participate in the oral single dosing, dose escalation study phase. In each group, subjects will be randomly assigned so that eight subjects receive active and three subjects receive placebo. It is planned for Groups 1 and 2, that a staggered 'sentinel' dose design will be used, with two sub-groups:
- The first will comprise of one placebo and one active subject.
- In the second, seven subjects will receive active and two will receive placebo after a review of the 24 h post-dose safety data of the first group.
Sentinel subject dosing will be performed in higher-dose groups if there is no measurable plasma GWP42006 in Group 1 or 2.
One group within the single dosing part (Group 3/dose level 3) will then receive an intravenous administration of 5 mg GWP42006 to allow assessment of bioavailability. There will be a minimum of seven days between doses.
Up to three further groups may be added for further evaluations, e.g. to assess additional dose levels or food effect. The need for additional groups will be based on a review of the safety, tolerability and PK data by the safety advisory committee.
Dose Escalation:
The planned dose levels are 25 mg (Group 1/dose level 1), 75 mg (Group 2/dose level 2), 200 mg (Group 3/dose level 3) and 400 mg (Group 4/dose level 4), with a maximum dose of 800 mg. Administration of each successive dose will be dependent on safety, tolerability and PK data of previous doses.
Part 2 Multiple Dosing:
The doses and dose regimens assessed in Part 2 will be selected based upon the safety, and PK data from Part 1 of the study.
It is planned that one group of 11 subjects will participate in the multiple dose phase, and subjects will be randomly assigned so that eight subjects receive active and three receive matching placebo. Each subject will receive the selected dose of GWP42006 or placebo once, twice or three times daily for a total of five days, with the final dose administered on the morning of Day 5.
Up to two further groups may be added for further evaluations, e.g. to assess a different dose level or a different dosing frequency. As for single dosing, the decision to include further groups will be taken based on safety, tolerability and PK data. All further groups would be added on blinded information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Group/dose level 1a | Experimental | Drug: GWP4200625 mg GWP42006 oral solution. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. |
| Group/dose level 1b | Placebo comparator | Drug: PlaceboMatching placebo for Group/dose level 1a. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. |
| Group/dose level 2a | Experimental | Drug: GWP4200675 mg GWP42006 oral solution. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. |
| Group/dose level 2b | Placebo comparator | Drug: PlaceboMatching placebo for Group/dose level 2a. As a safety precaution, subjects will be split into two sub-groups for sentinel dosing. On the first day of dosing , only two subjects will be dosed (randomisation schedule designed so that one placebo one active will be dosed on first day). Following a review of the safety data for the first set of subjects, the remaining subjects will be dosed. |
| Group/dose level 3a | Experimental | Drug: GWP42006200 mg GWP42006 oral solution (single dose) followed by an intravenous administration of 5 mg GWP42006 after the oral dose |
| Group/dose level 3b | Placebo comparator | Drug: PlaceboMatching placebo for Group/dose level 3a |
| Group/dose level 4a | Experimental | Drug: GWP42006400 mg GWP42006 oral solution |
| Group/dose level 4b | Placebo comparator | Drug: PlaceboMatching placebo for Group/dose level 4a |
| GWP42006 1, 2, or 3 times daily | Experimental | Drug: GWP42006Subjects will receive the selected dose of GWP42006 once, twice or three times daily (the number of daily doses and actual dose will be decided upon based on results from Part 1 of the study) for a total of 5 days, with the final dose given on the morning of Day 5. |
| Placebo 1, 2, or 3 times daily | Placebo comparator | Drug: PlaceboSubjects will receive placebo once, twice or three times daily (the number of daily doses and actual dose will be decided upon based on results from Part 1 of the study) for a total of 5 days, with the final dose given on the morning of Day 5. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy females of non-childbearing potential or healthy males
- Age 18 to 65 years, inclusive
- Body mass index of 18 to 30 kg/m2 inclusive or, if outside the range, considered not clinically significant by the investigator
- Must have no clinically significant abnormal findings on physical examination, vital signs, electrocardiogram, medical history, or clinical laboratory results during screening or Day -1 (admission)
- Must be willing and able to communicate and participate in the whole study
Key exclusion criteria (23 listed)
- Participation in a clinical research study/receiving an Investigational Medicinal Product within the 3 months prior to screening
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been randomised in this study
- History of any drug or alcohol abuse in the past 2 years, or current habituation to any medications or illegal drugs
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = 0.5 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
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 |
|---|---|---|
| PlaceboAlso: Placebo controlPlacebo control matched to the oral or intravenous experimental comparator drug | Drug | Group/dose level 1b, Group/dose level 2b, Group/dose level 3b, Group/dose level 4b, Placebo 1, 2, or 3 times daily |
| GWP42006Oral administration of 25 (Group/dose level 1a and 1b), 75 (Group/dose level 2a and 2b), 200 (Group/dose level 3a and 3b) and 400 mg GWP42006 (Group/dose level 4a and 4b), provided as 50 mg/mL GWP42006 solution in sesame oil containing flavourings and sweetener, for dilution on the day of dosing, as required. Additional intravenous administration of 5 mg GWP42006 and 10 mL Solutol HS 15 solution to Group/dose level 3a and 3b subjects. | Drug | GWP42006 1, 2, or 3 times daily, Group/dose level 1a, Group/dose level 2a, Group/dose level 3a, Group/dose level 4a |
Primary outcome
The incidence of adverse events as measure of subject safety
Time frame: Day 0 - Day 10
The number of subjects who experienced an adverse event during each arm of the study is presented.
3 secondary outcomes
To determine the plasma concentration time curves for GWP42006, 7-hydroxy-GWP42006 and 6-hydroxy-GWP42006 compounds, following escalating single doses and multiple doses of pure GWP42006.
Time frame: Pre-dose then 0, 0.04, 0.08, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 h post-dose
To investigate cognitive function following single ascending and multiples doses of GWP42006
Time frame: Admission (Day -1) and 2 h post-dose
To investigate gene expression following multiple doses of GWP42006
Time frame: Pre-dose on multiple dose Days 1-4 then 2 h post-dose on multiple dose Day 5
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 20 Dec 2022.
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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 GWP42006 in people with Epilepsy, run by Jazz Pharmaceuticals at 1 site in United Kingdom.
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 23 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 20 Dec 2022. 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 Kingdom. 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?
The incidence of adverse events as measure of subject safety (time frame: Day 0 - Day 10). 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 20 Dec 2022.