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Completed

NCT Number: NCT04906005

Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers

This single center, single ascending dose, double blind, randomized, placebo-controlled phase I trial will include male and female Japanese healthy volunteers. Within a 4-week run-in period before inclusion in the trial, healthy volunteers will be checked for inclusion/non-inclusion criteria and will then be randomized and administered with gadopiclenol or placebo. For each healthy volunteer, there will be a confinement period of one night before the inclusion visit and 2 days post administration at the clinical unit. The healthy volunteers will return to the clinical unit for safety visit 7 days after study product administration.

In each dose group, 6 healthy volunteers (3 male and 3 female) will receive gadopiclenol and 3 healthy volunteers (2M/1F or 1M/2F) will receive placebo (physiological saline solution, 0.9% sodium chloride) in one single intravenous administration.

Dose escalation from one group to the next group will be sequential and will be allowed only if the clinical and biological safety of all healthy volunteers from the previous tested dose is acceptable. The decision will be made by a Trial Safety Review Board (TSRB), consisting in members of Guerbet team and the principal investigator.

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Key information

Conditions

Pharmacokinetics

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hataka clinic

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A Japanese healthy volunteer is defined as being born in Japan and having both parents and four grandparents (maternal and paternal) who are ethnically Japanese and having Japanese lifestyle, including diet, as determined by participant's verbal report.
  • Good health status as determined by investigator according to past medical history, clinical examination, including 12 lead ECG, vital signs (blood pressure, pulse rate, respiratory rate and body temperature) and laboratory tests at screening and inclusion.

Exclusion criteria

  • Pregnant or breast-feeding female volunteer.
  • Having acute or chronic renal insufficiency, defined as an eGFR (estimated Glomerular Filtration Rate) <90mL/min/1.73 m2, calculated by using the Japanese coefficient-modified CKD-EPI formula.
  • With known contra-indication(s) to the use or with known sensitivity to one of the products under investigation or to drugs from a similar pharmaceutical class.
  • With known history of severe allergic or anaphylactic reactions to any allergen including drugs and contrast agents.

Treatment and study plan

Gadopiclenol

Drug

administration by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a saline flush of at least 5 mL at the same rate to ensure complete injection of the contrast agent.The gadopiclenol administration is performed by power injecto

Placebo

Drug

intravenous (IV) bolus injection at 2 mL/s, followed by a saline flush of at least 5 mL to be in the same conditions as for gadopiclenol administration.The gadopiclenol administration is performed by power injector

Primary outcomes

  1. Cmax

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

    Maximum concentrations measured, value taken directly from the observed concentration-time profiles

  2. Tmax

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

    Time corresponding to Cmax

  3. AUC 0-inf

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

    Area Under the observed concentration-time Curve from zero (time of drug administration) to infinity with extrapolation of the terminal phase. It will be obtained as follows: AUC 0-inf = AUC 0-T last + (Clast / β)

  4. t 1/2β

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

    Terminal elimination half-life of gadopiclenol calculated as follows:

    t 1/2β = ln 2 / β

  5. AUC extrap%

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

    Percentage of extrapolation of AUC from the last observation (Tlast) to infinity calculated as follows:

    Percentage of extrapolation of AUC from the last observation (Tlast) to infinity calculated as follows:

    Percentage of extrapolation of AUC from the last observation (Tlast) to infinity calculated as follows:

  6. CLT

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

    Total Clearance, calculated as CLT = Dose /AUC 0-inf

  7. Vdβ

    Time frame: from baseline (30 min before injection) to 24h post injection

    Volume of distribution, calculated as Vdβ = Dose / (AUC 0-inf x β)

  8. Ae

    Time frame: Before administration and during intervals 0-6hours, 6-24hours and 24-48hours after gadopiclenol administration

    Total amount of gadopiclenol excreted in urine

  9. CLR

    Time frame: Before administration and during intervals0-6hours, 6-24hours and 24-48hours after gadopiclenol administration

    Renal clearance, calculated as CLR = Ae / AUC 0-inf

Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo-Controlled, Single Ascending Dose Trial to Assess the Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers Phase I Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 28, 2021
Registry last updated
Oct 7, 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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