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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603106
• Other study ID #: GDX-44-003
• Secondary ID: 2013-004428-12
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 25, 2013
• Est. completion date: April 17, 2015

Study information

• Verified date: May 2021
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 17, 2015
• Est. primary completion date: April 17, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Part I: Subjects between 18 and 45 years old (inclusive), with a body mass index (BMI) of 18 to 30 kg/m² (exclusive) and in a good health.

• Part II: Patients 18 years old and older and having at least one brain lesion with a disruption of the blood brain barrier (BBB) and/or with abnormal vascularity in the brain. This/these lesion(s) must have been detected by previous imaging evaluation (Computed Tomography or MRI).

Related Conditions & MeSH terms

• Brain Lesion
• Healthy Volunteers

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology unit, SGS Life Science Services	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic (PK) Parameter Cmax	Cmax = maximum concentration measured. Blood samples were taken to assess the P03277 concentration.	From baseline (30 minutes before injection) to 24 hours post-injection
Primary	PK Parameter T1/2	T1/2 = terminal elimination half-life of the compound. Blood samples were taken to assess the P03277 concentration.	From baseline (30 minutes before injection) to 24 hours post-injection
Primary	PK Parameter Cl	Cl = total clearance. Blood samples were taken to assess the P03277 concentration.	From baseline (30 minutes before injection) to 24 hours post-injection
Primary	PK Parameter Vd	Vd = volume of distribution. Blood samples were taken to assess the P03277 concentration.	From baseline (30 minutes before injection) to 24 hours post-injection