Status:
COMPLETED
Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers
Lead Sponsor:
Guerbet
Conditions:
Pharmacokinetics
Eligibility:
All Genders
20-59 years
Phase:
PHASE1
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 inc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04906005
Start Date
May 10 2021
End Date
July 27 2021
Last Update
October 7 2021
Active Locations (1)
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1
Hataka clinic
Fukuoka, Japan