Safety and TolerabilityPhase 1GAB-001NCT03817346
Study of Ascending Single Oral Dose of GT-002 in Healthy Volunteers
A Phase 1 study testing GT-002 in people with Safety and Tolerability, run by Gabather AB at 1 site in Finland.
Trial summary
This study does not target any disease or condition in itself, but is evaluating the safety, tolerability and pharmacokinetics of single oral doses of GT-002 in the setting of healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability
- What is being tested?
- GT-002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteFinland
- Study dates
- 17 Dec 2018to 31 May 2019
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is willing and able to give written informed consent for participation in the study. Sufficient command of the Finnish language will be needed for informed consent and adequate communication with the study personnel.
- Healthy male subjects from 18 up to 45 years of age.
- Body mass index (BMI) from 18 kg/m2 up to 28 kg/m2.
- Body weight from 60 kg up to 120 kg.
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values as judged by the investigator at the time of the screening visit. A subject with a clinical abnormality or laboratory parameters outside of the reference range for the population being studied may be included at the investigator´s discretion provided the finding is unlikely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedures.
- Subjects must be willing to use condom or other contraceptive methods with a failure rate of < 1% and refrain from donating sperm from the date of dosing until one month after last dosing.
- -
Who cannot join
- Current or history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- History of any type of cancer.
- Subjects considered unlikely to comply with study procedures, restrictions and requirements
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product that is likely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedures
- Any clinically significant abnormalities in clinical chemistry, haematology, coagulation or urinalysis results at the time of screening visit as judged by the investigator
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus (HIV)
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- After 10 minutes of supine rest, abnormal vital signs defined as any of the following:
- Systolic blood pressure > 140 mm Hg (average of two measurements)
- Diastolic blood pressure > 90 mm Hg (average of two measurements)
- Heart rate < 40 or > 85 beats per minute (average of two measurements)
- Body temperature (auricular) ≥38oC
- Prolonged QTcF interval (>450 ms), clinically significant cardiac arrhythmia or any other clinically significant abnormalities in the resting ECG as judged by the investigator
- Intake of any medication, vitamin or mineral supplement product that could affect the outcome of the study, within 2 weeks prior to the first study treatment administration or less than 5 times the half-life of the medication. Possible prior use of enzyme inducing drugs will be considered case-by-case by the investigator.
- Any blood donation/blood loss > 250 ml during the 3 months prior to screening
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical trial that included drug treatment within 3 months of the administration of investigational product in this study. Subjects consented and screened but not dosed in previous phase I studies can be included in this study.
- Current or history of alcohol or drug abuse within the last 5 years, current excessive use of alcohol (current regular alcohol drinking of more than 24 units/week) or use of illicit drugs.
- Positive screen for drugs of abuse at screening or on admission to the unit or positive breath test result for alcohol at screening or on admission to the unit prior to the administration of investigational product.
- Known allergy to the components used in the formulation of GT-002.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, and chewing tobacco) up to five doses per week is allowed before screening visit.
- Intake of >5 cups of coffee/day or the corresponding amount of other caffeine containing beverages (e.g. energy drinks containing caffeine) during the study.
- Subjects who have planned any scheduled invasive treatment or medical/surgical procedure during the study period.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled Study in Healthy Male Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Ascending Single Oral Doses of GT-002
This study does not target any disease or condition in itself, but is evaluating the safety, tolerability and pharmacokinetics of single oral doses of GT-002 in the setting of healthy volunteers.
A longer-term objective is to apply the findings from this study to design and later conduct a clinical development programme of GT-002 as a medication to treat schizophrenia.
- Conditions
- Safety and Tolerability
- Being tested
- GT-002, Placebo oral capsule
- Keywords
- Safety, Tolerability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT-002Drug
Single ascending dose
Placebo oral capsuleDrug
Comparator single ascending dose
| Study group | Role | What they receive |
|---|---|---|
| Experimental GT-002 SAD | Active comparator | Healthy volunteers meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 7 dose ascending cohorts) to receive either GT-002 or placebo. The study drug (GT-002 or placebo) will be administered orally as a single dose. Six of out 8 subjects per cohort will be randomized to receive GT-002. Receives: Drug: GT-002 |
| Experimental Placebo oral capsule SAD | Placebo comparator | Healthy volunteers meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 7 dose ascending cohorts) to receive either GT-002 or placebo. The study drug (GT-002 or placebo) will be administered orally as a single dose. Two of out 8 subjects per cohort will be randomized to receive GT-002. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
To evaluate the safety and tolerability GT-002 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs
Measured: Day 1 to day 3
Secondary outcomes (6)
Pharmacokinetic parameter AUCt
Area under the curve from the time of dosing until the last quantifiable concentration
Measured: Day1 to day 3
Pharmacokinetic parameter AUC0-24
Area under the curve from the time of dosing until 24 hours post dosing
Measured: Day1 to day 2
Pharmacokinetic parameter AUC0-infinity
Area under the curve from the time of dosing extrapolated to infinity
Measured: day 1 to day 3
Pharmacokinetic parameter Cmax
Maximum concentration (Cmax)
Measured: Day 1 to day 3
tmax
Time to maximum concentration
Measured: Day 1 to day 3
t1/2
Apparent terminal elimination half-life
Measured: Day 1 to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start17 Dec 2018
- Primary completion31 Mar 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and TolerabilityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single ascending dose
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gabather AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Smerud Medical Research International AS
- Responsible party
- Sponsor
- Investigators
- Yvonne Peltonen, Study chair, Smerud Medical Research Finland Ab/Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817346
- Sponsor's protocol ID
- GAB-001
- Acronym
- GAB-001
- Status last verified
- Feb 2020
- First submitted
- 11 Dec 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-blind, Placebo-controlled Study in Healthy Male Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Ascending Single Oral Doses of GT-002
- ClinicalTrials.gov ID
- NCT03817346
- Acronym / sponsor ID
- GAB-001 / GAB-001
- Conditions
- Safety and Tolerability
- Keywords
- Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gabather ABIndustry (pharma, biotech, devices)
- Collaborators
- Smerud Medical Research International AS
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 25 Jan 2019 (actual)
- 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.
This study does not target any disease or condition in itself, but is evaluating the safety, tolerability and pharmacokinetics of single oral doses of GT-002 in the setting of healthy volunteers.
A longer-term objective is to apply the findings from this study to design and later conduct a clinical development programme of GT-002 as a medication to treat schizophrenia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Single ascending dose
| Arm | Type | Receives |
|---|---|---|
| Experimental GT-002 SAD | Active comparator | Drug: GT-002Healthy volunteers meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 7 dose ascending cohorts) to receive either GT-002 or placebo. The study drug (GT-002 or placebo) will be administered orally as a single dose. Six of out 8 subjects per cohort will be randomized to receive GT-002. |
| Experimental Placebo oral capsule SAD | Placebo comparator | Drug: Placebo oral capsuleHealthy volunteers meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 7 dose ascending cohorts) to receive either GT-002 or placebo. The study drug (GT-002 or placebo) will be administered orally as a single dose. Two of out 8 subjects per cohort will be randomized to receive GT-002. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is willing and able to give written informed consent for participation in the study. Sufficient command of the Finnish language will be needed for informed consent and adequate communication with the study personnel.
- Healthy male subjects from 18 up to 45 years of age.
- Body mass index (BMI) from 18 kg/m2 up to 28 kg/m2.
- Body weight from 60 kg up to 120 kg.
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values as judged by the investigator at the time of the screening visit. A subject with a clinical abnormality or laboratory parameters outside of the reference range for the population being studied may be included at the investigator´s discretion provided the finding is unlikely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedures.
Key exclusion criteria (22 listed)
- Current or history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- History of any type of cancer.
- Subjects considered unlikely to comply with study procedures, restrictions and requirements
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product that is likely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedures
- Any clinically significant abnormalities in clinical chemistry, haematology, coagulation or urinalysis results at the time of screening visit as judged by the investigator
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 |
|---|---|---|
| GT-002Single ascending dose | Drug | Experimental GT-002 SAD |
| Placebo oral capsuleComparator single ascending dose | Drug | Experimental Placebo oral capsule SAD |
Primary outcome
Adverse Events (AEs)
Time frame: Day 1 to day 3
To evaluate the safety and tolerability GT-002 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs
6 secondary outcomes
Pharmacokinetic parameter AUCt
Time frame: Day1 to day 3
Pharmacokinetic parameter AUC0-24
Time frame: Day1 to day 2
Pharmacokinetic parameter AUC0-infinity
Time frame: day 1 to day 3
Pharmacokinetic parameter Cmax
Time frame: Day 1 to day 3
tmax
Time frame: Day 1 to day 3
t1/2
Time frame: Day 1 to day 3
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 5 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Yvonne Peltonen study chair
Smerud Medical Research Finland Ab/Oy
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 GT-002 in people with Safety and Tolerability, run by Gabather AB at 1 site in Finland.
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 7 inclusion and 22 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 5 Feb 2020. 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 Finland. 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?
Adverse Events (AEs) (time frame: Day 1 to day 3). 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 5 Feb 2020.