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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005791-19 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GEH200486 Cohort 1 | Experimental | Participants will receive 0.05 mmol/kg of GE200486 0.5 M injection |
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| GEH200486 Cohort 2 | Experimental | Participants will receive 0.1 mmol/kg of GE200486 0.5 M injection |
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| GEH200486 Cohort 3 | Experimental | Participants will receive 0.2 mmol/kg of GE200486 0.5 M injection |
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| GEH200486 Cohort 4 | Experimental | Participants will receive 0.3 mmol/kg of GE200486 0.5 M injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GE200486 0.5M Injection | Drug | Single administration by intravenous (IV) hand injection without dilution, followed by a 5mL saline flush |
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| Measure | Description | Time Frame |
|---|---|---|
| Collection of occurrence of IMP-related SAEs | After administration of IMP until 72 hours post dose (up to 17 days post dose) | |
| Collection of TEAEs | After administration of IMP until 72 hours post dose (up to 17 days post dose) | |
| Collection of AEs | After administration of IMP until 72 hours post dose (up to 17 days post dose) | |
| Injection site monitoring findings at pre-specified time points. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francois Tranquart, MD, PhD | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rikshospitalet | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38038701 | Derived | 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. |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| 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 | 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 | 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 | 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 | Baseline, 10 minutes, 30 minutes, 1 hour, 4 hours, 24 hours, 48 hours and 72 hours post IMP administration |
| Baseline (prior to IMP administration) up to 72 hours |