NCT05569278 is a Phase 1 clinical trial of GE200486 0.5M Injection in Pharmacokinetics, sponsored by GE Healthcare.

Who is sponsoring NCT05569278?

NCT05569278 is sponsored by GE Healthcare.

What drugs are being tested in NCT05569278?

Interventions in NCT05569278: GE200486 0.5M Injection.

What condition does NCT05569278 study?

NCT05569278 studies Pharmacokinetics.

Is NCT05569278 still recruiting?

NCT05569278 is currently completed. Last updated 6 July 2023.

Last reviewed 2023-07-06 · How we verify

NCT05569278

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Pharmacokinetics of GEH200486 in Healthy Volunteers

Completed Phase 1 Last updated 6 July 2023

What this trial tests

Phase 1 trial testing GE200486 0.5M Injection in Pharmacokinetics in 15 participants. Completed in 29 November 2022.

Timeline

22 August 2022

Primary endpoint
29 November 2022

29 November 2022

Quick facts

Lead sponsor	GE Healthcare
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	basic science
Enrollment	15
Start date	22 August 2022
Primary completion	29 November 2022
Estimated completion	29 November 2022
Sites	1 location across Norway

Drugs / interventions tested

GE200486 0.5M Injection — full drug profile →

Conditions studied

Pharmacokinetics — all drugs for Pharmacokinetics →

Sponsor

GE Healthcare — full company profile →

Who can join

Adults 18 to 55, any sex, with Pharmacokinetics. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Divalent Manganese Complexes as Potential Replacements for Gadolinium-Based Contrast Agents.
Caravan P. · · 2024 · cited 23× · PMID 38038701 · DOI 10.1097/rli.0000000000001053
Oral Manganese Chloride Tetrahydrate: A Novel Magnetic Resonance Liver Imaging Agent for Patients With Renal Impairment: Efficacy, Safety, and Clinical Implication.
Brismar TB, Geisel D, Kartalis N, Madrazo BL, et al · · 2024 · cited 11× · PMID 37934630 · DOI 10.1097/rli.0000000000001042

Verify or expand the search:

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Other GE Healthcare trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05569278 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GE Healthcare
Last refreshed: 6 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05569278.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing