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Completed

NCT Number: NCT03603106

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

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.

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Key information

Conditions

Healthy Volunteers Brain Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Pharmacology unit, SGS Life Science Services

Antwerp, 2060, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

P03277

Drug

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.

Other names: Gadopiclenol

Placebo

Drug

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.

Other names: NaCl 0.9%

Primary outcomes

  1. Pharmacokinetic (PK) Parameter Cmax

    Time frame: From baseline (30 minutes before injection) to 24 hours post-injection

    Cmax = maximum concentration measured. Blood samples were taken to assess the P03277 concentration.

  2. PK Parameter T1/2

    Time frame: From baseline (30 minutes before injection) to 24 hours post-injection

    T1/2 = terminal elimination half-life of the compound. Blood samples were taken to assess the P03277 concentration.

  3. PK Parameter Cl

    Time frame: From baseline (30 minutes before injection) to 24 hours post-injection

    Cl = total clearance. Blood samples were taken to assess the P03277 concentration.

  4. PK Parameter Vd

    Time frame: From baseline (30 minutes before injection) to 24 hours post-injection

    Vd = volume of distribution. Blood samples were taken to assess the P03277 concentration.

Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 27, 2018
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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