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

NCT03603106 | Completed Phase 1 Results

• 2 other identifiers: GDX-44-0032013-004428-12
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Brain Lesion

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Part I (Phase I)

EXPERIMENTAL

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; Drug: Placebo

Part II (Phase IIA)

EXPERIMENTAL

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

Interventions

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.

Also known as: Gadopiclenol

Part I (Phase I); Part II (Phase IIA)

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.

Also known as: NaCl 0.9%

Part I (Phase I)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Guerbet: lead

Study Sites (1)

Clinical Pharmacology unit, SGS Life Science Services

Antwerp, 2060, Belgium

Location

Related Publications (1)

• Hao J, Bourrinet P, Desche P. Assessment of Pharmacokinetic, Pharmacodynamic Profile, and Tolerance of Gadopiclenol, A New High Relaxivity GBCA, in Healthy Subjects and Patients With Brain Lesions (Phase I/IIa Study). Invest Radiol. 2019 Jul;54(7):396-402. doi: 10.1097/RLI.0000000000000556.

  PMID: 30870257 DERIVED

MeSH Terms

Interventions

gadopiclenol; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Jing Hao, MD
• Organization: Guerbet

jing.hao@guerbet.com

+33 (0) 1 45 91 50 00

Study Officials

• Wouter Haazen, MD

  SGS Clinical Pharmacology Unit

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 27, 2018
• Study Start: November 25, 2013
• Primary Completion: April 17, 2015
• Study Completion: April 17, 2015
• Last Updated: May 14, 2021
• Results First Posted: July 12, 2019

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)