Clinical trial NCT04906005: Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2021-05-28
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cmax
timeFrame: from baseline (30 minutes before injection) to 24hours post injection
measure: Tmax
timeFrame: from baseline (30 minutes before injection) to 24hours post injection
measure: AUC 0-inf
timeFrame: from baseline (30 minutes before injection) to 24hours post injection
measure: t 1/2β
timeFrame: from baseline (30 minutes before injection) to 24hours post injection
measure: AUC extrap%
timeFrame: from baseline(30 minutes before injection) to 24hours post injection
measure: CLT
timeFrame: from baseline (30 minutes before injection) to 24hours post injection
measure: Vdβ
timeFrame: from baseline (30 min before injection) to 24h post injection
measure: Ae
timeFrame: Before administration and during intervals 0-6hours, 6-24hours and 24-48hours after gadopiclenol administration
measure: CLR
timeFrame: Before administration and during intervals0-6hours, 6-24hours and 24-48hours after gadopiclenol administration
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Hataka clinic
Study officials:
affiliation: Guerbet
name: Jing Hao
role: STUDY_CHAIR
References: