Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT03603106
Status:
COMPLETED
Last Update Posted:
2021-05-14
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions
Sponsor:
Guerbet
Organization:
Study Overview
Official Title:
Assessment of Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study was to evaluate the safety (clinical and biological) and pharmacokinetics (plasma and urine) profile of P03277 following single administration at ascending dose levels in healthy subjects.
Detailed Description:
This single-center, single ascending dose, phase I/IIa study was divided into 2 parts, involving both healthy subjects and patients with brain lesions:
* Study Part I included healthy subjects: double-blind, randomized, placebo control;
* Study Part II included patients with brain lesions: open-label.
In Part I, the following 6 dosing groups were investigated:
* Group 1: 0.025 mmol/kg
* Group 2: 0.05 mmol/kg
* Group 3: 0.075 mmol/kg
* Group 4: 0.1 mmol/kg
* Group 5: 0.2 mmol/kg
* Group 6: 0.3 mmol/kg
Healthy subjects were included and were then administered with P03277 or placebo and were to undergo MRI examination according to the randomization scheme.
In Part II, the following 4 doses groups were investigated:
* Group 7: 0.05 mmol/kg
* Group 8: 0.075 mmol/kg
* Group 9: 0.1 mmol/kg
* Group 10: 0.2 mmol/kg
Patients with brain lesions were included and were then administered with P03277 and underwent MRI examination.
* Study Part I included healthy subjects: double-blind, randomized, placebo control;
* Study Part II included patients with brain lesions: open-label.
In Part I, the following 6 dosing groups were investigated:
* Group 1: 0.025 mmol/kg
* Group 2: 0.05 mmol/kg
* Group 3: 0.075 mmol/kg
* Group 4: 0.1 mmol/kg
* Group 5: 0.2 mmol/kg
* Group 6: 0.3 mmol/kg
Healthy subjects were included and were then administered with P03277 or placebo and were to undergo MRI examination according to the randomization scheme.
In Part II, the following 4 doses groups were investigated:
* Group 7: 0.05 mmol/kg
* Group 8: 0.075 mmol/kg
* Group 9: 0.1 mmol/kg
* Group 10: 0.2 mmol/kg
Patients with brain lesions were included and were then administered with P03277 and underwent MRI examination.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-004428-12 | EUDRACT_NUMBER | None | View |