PharmacokineticsPhase 1NCT05569278
Safety and Pharmacokinetics of GEH200486 in Healthy Volunteers
A Phase 1 study testing GE200486 0.5M Injection in people with Pharmacokinetics, run by GE Healthcare at 1 site in Norway.
Trial summary
This is a single center, prospective, dose escalation study (4 different dose levels) for a novel magnetic resonance imaging (MRI) contrast agent, in male and female healthy volunteers . The study is primarily designed to collect safety data. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- GE200486 0.5M Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- 22 Aug 2022to 29 Nov 2022
- 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
- The subject is between 18 to 55 years of age
- The subject has no currently active significant medical illness or history of chronic medical illness.
- The subject has no clinically significant deviation from normal ranges in physical examination, ECG, and clinical laboratory parameters.
- The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed, and is willing to allow the study Investigator to make the subject's medical records available to GE Healthcare
- The subject is able and willing to comply with all study procedures as described in the protocol.
- Female subjects: The subject is a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (amenorrhoea duration of at least 12 consecutive months), or non- lactating, or if of childbearing potential the results of a urine human chorionic gonadotropin pregnancy test, performed at screening and on the day of dosing, prior to administration (with the result known before investigational medicinal product [IMP] administration), must be negative. Women of childbearing potential must use adequate contraception from screening until 30 days after administration of IMP. Such methods include: hormonal contraception including oral contraceptives; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner; sexual abstinence.
- Male subjects: The subject is a male who is either surgically sterile or males who are sexually active with a partner of childbearing potential must use adequate contraception from screening until 30 days after administration of IMP. Such methods include: vasectomy; sexual abstinence. Male subjects must agree not to donate sperm from screening through 30 days after administration of IMP
Who cannot join
- Subjects who are unable to undergo any of the study procedures.
- Subjects with any significant currently active or chronic medical illness (e.g., cardiovascular disease, renal impairment, hepatic dysfunction, Parkinson's disease) or recent significant trauma (e.g., motor vehicle accident) or any condition that may have disrupted and/or increased permeability of the blood-brain barrier.
- Subjects with any major surgery within 4 weeks prior to enrolment or planned within 2 weeks after completion of the study.
- Subjects who have a positive urine screen for alcohol and/or recreational drugs at screening or before dosing.
- Subjects who are taking prescribed medication (other than contraception) within 2 weeks prior to enrolment or anticipate using prescribed medication (other than oral contraception) during the enrolment period through study follow-up. Limited use of non- prescription medications which in the Investigator's opinion will not affect subject safety or the overall results of the study may be permitted (e.g., acetaminophen/paracetamol) on a case-by-case basis following approval by the Sponsor.
- Subjects who have undergone a contrast-enhanced (CE) imaging procedure (CE-MRI, CE computed tomography [CT]) during the 30 days prior to dosing.
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- Subjects who are taking any concomitant medications or dietary supplements that are known to increase blood levels of Mn, Zn, copper (Cu), or iron (Fe) for the duration of the study.
- Subjects who have serious allergic history or known or suspected allergy to the study drug GEH200486 0.5 M Injection or study drug ingredients.
- Subjects who present with any clinically active, serious, life-threatening disease, medical or psychiatric condition, known abuse or misuse of prescription or non-prescription drugs and subjects whom the Investigator judges to be unsuitable for participation in the study for any reason.
- Subjects with previous (within 30 days before administration of IMP or within 5 half-lives of the investigational treatment of the previous study, whichever is longer) or concomitant participation in another clinical study with IMP(s).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single Centre, Single Ascending Dose Safety Study of GEH200486 in Healthy Volunteers
This is a single center, prospective, dose escalation study (4 different dose levels) for a novel magnetic resonance imaging (MRI) contrast agent, in male and female healthy volunteers . The study is primarily designed to collect safety data. In addition, researchers want to learn more about how the novel contrast agent, GEH200486 circulates and is eliminated from the body (pharmacokinetics) after injection in healthy volunteers. Up to 24 healthy volunteers will be enrolled and will each receive a single administration of one of the 4 doses of GEH200486. Each healthy volunteer will stay at the clinical unit for the first 24 hours post injection and return for up to 3 follow-up visits with 1 additional follow-up phone call.
Dose escalation from one dose group to the next dose group will be sequential and only be allowed if the clinical safety of all healthy volunteers from the tested dose group is acceptable, as assessed by an independent safety committee, members of GEHC team and the principal investigator.
- Conditions
- Pharmacokinetics
- Being tested
- GE200486 0.5M Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GE200486 0.5M InjectionDrug
Single administration by intravenous (IV) hand injection without dilution, followed by a 5mL saline flush
| Study group | Role | What they receive |
|---|---|---|
| GEH200486 Cohort 1 | Experimental | Participants will receive 0.05 mmol/kg of GE200486 0.5 M injection Receives: Drug: GE200486 0.5M Injection |
| GEH200486 Cohort 2 | Experimental | Participants will receive 0.1 mmol/kg of GE200486 0.5 M injection Receives: Drug: GE200486 0.5M Injection |
| GEH200486 Cohort 3 | Experimental | Participants will receive 0.2 mmol/kg of GE200486 0.5 M injection Receives: Drug: GE200486 0.5M Injection |
| GEH200486 Cohort 4 | Experimental | Participants will receive 0.3 mmol/kg of GE200486 0.5 M injection Receives: Drug: GE200486 0.5M Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of occurrence of IMP-related SAEs
Measured: After administration of IMP until 72 hours post dose (up to 17 days post dose)
Collection of TEAEs
Measured: After administration of IMP until 72 hours post dose (up to 17 days post dose)
Collection of AEs
Measured: After administration of IMP until 72 hours post dose (up to 17 days post dose)
Injection site monitoring findings at pre-specified time points.
Measured: Continuous monitoring from IMP injection up to 24 hours
Change from baseline in the results of serum biochemistry test results at pre-specified time points.
In this context, baseline is defined as the pre-treatment assessment at the screening visit. The occurrence of post injection values outside of normal limits and changes from baseline will be summarized.
Measured: Baseline, 1 hour, 4 hours, 24 hours, 48 hours and 72 hours post IMP administration
Change from baseline in the results of urinalysis at pre-specified time points.
In this context, baseline is defined as the pre-treatment assessment at the screening visit. The occurrence of post injection values outside of normal limits and changes from baseline will be summarized.
Measured: Baseline, 48 hours and 72 hours post IMP administration
Change from baseline in the results of haematology at pre-specified time points.
In this context, baseline is defined as the pre-treatment assessment at the screening visit. The occurrence of post injection values outside of normal limits and changes from baseline will be summarized.
Measured: Baseline, 1 hour, 4 hours, 24 hours, 48 hours and 72 hours post IMP administration
Measure of blood pressure in mmHg at pre-specified time points
Measured: Baseline, 10 minutes, 30 minutes, 1 hour, 4 hours, 24 hours, 48 hours and 72 hours post IMP administration
Measure of body temperature as degree C at pre-specified time points
Measured: Baseline, 10 minutes, 30 minutes, 1 hour, 4 hours, 24 hours, 48 hours and 72 hours post IMP administration
Measure of heart rate as bpm at pre-specified time points
Measured: Baseline, 10 minutes, 30 minutes, 1 hour, 4 hours, 24 hours, 48 hours and 72 hours post IMP administration.
Measure of respiratory rate per min at pre-specified time points
Measured: Baseline, 10 minutes, 30 minutes, 1 hour, 4 hours, 24 hours, 48 hours and 72 hours post IMP administration
Secondary outcomes (2)
Pharmacokinetic assessment
AUC0-t Area under the concentration versus time curve (AUC) from time zero to the last measurable concentration, calculated using the linear up/log down trapezoidal rule.
Measured: pre-dose to 24 hours
Change from baseline in the results of ECG examinations (PR interval, QTc, QRS and RR interval) at pre-specified time points.
Measured: Baseline (prior to IMP administration) up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start22 Aug 2022
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francois Tranquart, MD, PhD, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569278
- Sponsor's protocol ID
- GE-227-001
- Other IDs
- 2021-005791-19
- Status last verified
- Jul 2023
- First submitted
- 17 Aug 2022
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caravan P. Divalent Manganese Complexes as Potential Replacements for Gadolinium-Based Contrast Agents. Invest Radiol. 2024 Feb 1;59(2):187-196. doi: 10.1097/RLI.0000000000001053. Epub 2023 Dec 1.
PubMed 38038701
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single Centre, Single Ascending Dose Safety Study of GEH200486 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05569278
- Acronym / sponsor ID
- GE-227-001
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 6 Oct 2022 (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 is a single center, prospective, dose escalation study (4 different dose levels) for a novel magnetic resonance imaging (MRI) contrast agent, in male and female healthy volunteers . The study is primarily designed to collect safety data. In addition, researchers want to learn more about how the novel contrast agent, GEH200486 circulates and is eliminated from the body (pharmacokinetics) after injection in healthy volunteers. Up to 24 healthy volunteers will be enrolled and will each receive a single administration of one of the 4 doses of GEH200486. Each healthy volunteer will stay at the clinical unit for the first 24 hours post injection and return for up to 3 follow-up visits with 1 additional follow-up phone call.
Dose escalation from one dose group to the next dose group will be sequential and only be allowed if the clinical safety of all healthy volunteers from the tested dose group is acceptable, as assessed by an independent safety committee, members of GEHC team and the principal investigator.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GEH200486 Cohort 1 | Experimental | Drug: GE200486 0.5M InjectionParticipants will receive 0.05 mmol/kg of GE200486 0.5 M injection |
| GEH200486 Cohort 2 | Experimental | Drug: GE200486 0.5M InjectionParticipants will receive 0.1 mmol/kg of GE200486 0.5 M injection |
| GEH200486 Cohort 3 | Experimental | Drug: GE200486 0.5M InjectionParticipants will receive 0.2 mmol/kg of GE200486 0.5 M injection |
| GEH200486 Cohort 4 | Experimental | Drug: GE200486 0.5M InjectionParticipants will receive 0.3 mmol/kg of GE200486 0.5 M injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The subject is between 18 to 55 years of age
- The subject has no currently active significant medical illness or history of chronic medical illness.
- The subject has no clinically significant deviation from normal ranges in physical examination, ECG, and clinical laboratory parameters.
- The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed, and is willing to allow the study Investigator to make the subject's medical records available to GE Healthcare
- The subject is able and willing to comply with all study procedures as described in the protocol.
Key exclusion criteria (10 listed)
- Subjects who are unable to undergo any of the study procedures.
- Subjects with any significant currently active or chronic medical illness (e.g., cardiovascular disease, renal impairment, hepatic dysfunction, Parkinson's disease) or recent significant trauma (e.g., motor vehicle accident) or any condition that may have disrupted and/or increased permeability of the blood-brain barrier.
- Subjects with any major surgery within 4 weeks prior to enrolment or planned within 2 weeks after completion of the study.
- Subjects who have a positive urine screen for alcohol and/or recreational drugs at screening or before dosing.
- Subjects who are taking prescribed medication (other than contraception) within 2 weeks prior to enrolment or anticipate using prescribed medication (other than oral contraception) during the enrolment period through study follow-up. Limited use of non- prescription medications which in the Investigator's opinion will not affect subject safety or the overall results of the study may be permitted (e.g., acetaminophen/paracetamol) on a case-by-case basis following approval by the Sponsor.
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 |
|---|---|---|
| GE200486 0.5M InjectionSingle administration by intravenous (IV) hand injection without dilution, followed by a 5mL saline flush | Drug | GEH200486 Cohort 1, GEH200486 Cohort 2, GEH200486 Cohort 3, GEH200486 Cohort 4 |
Primary outcome
Collection of occurrence of IMP-related SAEs
Time frame: After administration of IMP until 72 hours post dose (up to 17 days post dose)
Collection of TEAEs
Time frame: After administration of IMP until 72 hours post dose (up to 17 days post dose)
Collection of AEs
Time frame: After administration of IMP until 72 hours post dose (up to 17 days post dose)
Injection site monitoring findings at pre-specified time points.
Time frame: Continuous monitoring from IMP injection up to 24 hours
Change from baseline in the results of serum biochemistry test results at pre-specified time points.
Time frame: Baseline, 1 hour, 4 hours, 24 hours, 48 hours and 72 hours post IMP administration
In this context, baseline is defined as the pre-treatment assessment at the screening visit. The occurrence of post injection values outside of normal limits and changes from baseline will be summarized.
Change from baseline in the results of urinalysis at pre-specified time points.
Time frame: Baseline, 48 hours and 72 hours post IMP administration
In this context, baseline is defined as the pre-treatment assessment at the screening visit. The occurrence of post injection values outside of normal limits and changes from baseline will be summarized.
Change from baseline in the results of haematology at pre-specified time points.
Time frame: Baseline, 1 hour, 4 hours, 24 hours, 48 hours and 72 hours post IMP administration
In this context, baseline is defined as the pre-treatment assessment at the screening visit. The occurrence of post injection values outside of normal limits and changes from baseline will be summarized.
Measure of blood pressure in mmHg at pre-specified time points
Time frame: Baseline, 10 minutes, 30 minutes, 1 hour, 4 hours, 24 hours, 48 hours and 72 hours post IMP administration
Measure of body temperature as degree C at pre-specified time points
Time frame: Baseline, 10 minutes, 30 minutes, 1 hour, 4 hours, 24 hours, 48 hours and 72 hours post IMP administration
Measure of heart rate as bpm at pre-specified time points
Time frame: Baseline, 10 minutes, 30 minutes, 1 hour, 4 hours, 24 hours, 48 hours and 72 hours post IMP administration.
Measure of respiratory rate per min at pre-specified time points
Time frame: Baseline, 10 minutes, 30 minutes, 1 hour, 4 hours, 24 hours, 48 hours and 72 hours post IMP administration
2 secondary outcomes
Pharmacokinetic assessment
Time frame: pre-dose to 24 hours
Change from baseline in the results of ECG examinations (PR interval, QTc, QRS and RR interval) at pre-specified time points.
Time frame: Baseline (prior to IMP administration) up to 72 hours
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 Jul 2023.
- Derived from this study: PubMed 38038701Caravan P. Divalent Manganese Complexes as Potential Replacements for Gadolinium-Based Contrast Agents. Invest Radiol. 2024 Feb 1;59(2):187-196. doi: 10.1097/RLI.0000000000001053. Epub 2023 Dec 1.
- 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.
Francois Tranquart, MD, PhD study director
GE Healthcare
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 GE200486 0.5M Injection in people with Pharmacokinetics, run by GE Healthcare at 1 site in Norway.
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 10 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 Jul 2023. 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 Norway. 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. 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?
Collection of occurrence of IMP-related SAEs (time frame: After administration of IMP until 72 hours post dose (up to 17 days post dose)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05569278, which also lists 1 linked publication.
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 Jul 2023.