NCT03603106

Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions

Assessment of Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Brain Lesion

Interventions

Type	Name	Description
DRUG	P03277	Part I: P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s. Part II: P03277 was administered intravenously with a flow rate of 2 mL/s.
DRUG	Placebo	Part I: Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s. Part II: Placebo was administered intravenously with a flow rate of 2 mL/s.

Timeline

• Start date: 2013-11-25
• Primary completion: 2015-04-17
• Completion: 2015-04-17
• First posted: 2018-07-27
• Last updated: 2021-05-14
• Results posted: 2019-07-12

Locations

1 site across 1 country: Belgium