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

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ClinicalTrials.gov Identifier: NCT03603106
Recruitment Status : Completed
First Posted : July 27, 2018
Results First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Guerbet

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Brain Lesion Drug: P03277 Drug: Placebo Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Part I: Sequential administration within each group of healthy subjects was established.

Part II: The administration to patients within the same day was sequential to ensure the well-being of the patients. At least a 1-hour interval between 2 administrations had to be respected.

Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Assessment of Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions
Actual Study Start Date : November 25, 2013
Actual Primary Completion Date : April 17, 2015
Actual Study Completion Date : April 17, 2015

Arm Intervention/treatment
Experimental: Part I (Phase I)
In each dose group (0.025, 0.05, 0.075, 0.1, 0.2 and 0.3 mmol/kg), 9 healthy subjects were to be included: 6 subjects received P03277 and 3 subjects received placebo in one single intravenous administration.
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.

Other Name: Gadopiclenol

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.

Other Name: NaCl 0.9%

Experimental: Part II (Phase IIA)
In each dose group (0.05, 0.075, 0.1 and 0.2 mmol/kg), all 3 patients received one single intravenous administration of P03277.
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.

Other Name: Gadopiclenol




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603106


Locations
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Belgium
Clinical Pharmacology unit, SGS Life Science Services
Antwerpen, Belgium, 2060
Sponsors and Collaborators
Guerbet
Investigators
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Principal Investigator: Wouter Haazen, MD SGS Clinical Pharmacology Unit

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT03603106     History of Changes
Other Study ID Numbers: GDX-44-003
2013-004428-12 ( EudraCT Number )
First Posted: July 27, 2018    Key Record Dates
Results First Posted: July 12, 2019
Last Update Posted: July 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No