A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, SINGLE-ASCENDING DOSE TRIAL TO ASSESS THE PHARMACOKINETICS AND SAFETY OF GADOPICLENOL IN JAPANESE HEALTHY VOLUNTEERS Phase 1 Clinical Trial

JRCT ID: jRCT2071210029

Registered date:28/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Intended for CNS and Body MRI contrast enhancement in adults and children from 2 years old
• Date of first enrollment: 31/05/2021
• Target sample size: 27
• Study type: Interventional

Intervention(s)

- Investigational Medicinal Product (IMP) 1: gadopiclenol
20 mL vial of gadopiclenol, 0.5M.
Three doses of gadopiclenol will be investigated: 0.025, 0.05, and 0.1 mmol/kg BW administered by single intravenous (IV) bolus injection.
- Investigational Medicinal Product (IMP) 2: Placebo
10 mL ampoule of NaCl 0.9% will be used as placebo.

For both products, the injection rate is 2 mL/second followed by a saline flush using power injector.

Outcome(s)

• Primary Outcome: Pharmacokinetics (plasma and urine)
• Secondary Outcome: Clinical and Biological Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 60age old
• Gender: Both

Include criteria

1. Age between 20 and 60 years old (exclusive).
2. Body Mass Index (BMI) of 18 to 25 kg/m2 (exclusive).
3. 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.
4. Male and/or female, able and willing to participate in the trial.
5. Having read the information and provided his/her consent to participate in writing by dating and signing the informed consent prior to any trial related procedure being conducted.
6. Female volunteer must have effective medically approved contraception until the last trial visit if with childbearing potential or with amenorrhea for less than 12 months or must be surgically sterilized or post-menopausal (>2 years amenorrhea).
7. Female volunteer under effective contraception must have a documented negative urine pregnancy test at screening and within 24 hours prior to IMP administration.
8. Affiliated to national health insurance according to local regulatory requirements.

*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.

Exclude criteria

Japanese healthy volunteer presenting with one or more of the following non-inclusion criteria must not be included in the trial:
1. Pregnant or breast-feeding female volunteer.
2. 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.
3. With known class III/IV congestive heart failure according to the New York Heart Association Classification.
4. Having received any contrast agent within 1 week before inclusion or being scheduled to receive any contrast agent within 1 week after inclusion.
5. 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.
6. With known history of severe allergic or anaphylactic reactions to any allergen including drugs and contrast agents.
7. Having received any investigational medicinal product or medical device within 30 days before gadopiclenol injection.
8. Inability or unwillingness to cooperate with the requirements of this trial.
9. With anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the healthy volunteer's safety or her/his ability to participate to the trial.
10. Unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the trial.
11. Using any prescription of drugs (except for contraceptive pills), herbal supplements and/or over-the counter (OTC) medication, dietary supplements within 2 weeks prior to inclusion.
12. Having excessive consumption of alcohol (more than 2 drinks per day), tobacco (over 10 cigarettes/day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day), grapefruit juice or drug abuse.
13. Having planned to receive treatment such as diuretics or blood transfusion during the course of the trial until Safety Visit at day8, that would alter the evaluation of gadopiclenol pharmacokinetics parameters.
14. Having any planned intervention during the course of the trial.
15. Previously randomized in this trial.
16. Related to the Investigator or any other trial staff or relative directly involved in the trial conduct.
17. Any condition which, based on the investigator's clinical judgment, would prevent the healthy volunteer from participating in all trial assessments and visits (for example: mental or physical incapacity, language comprehension, geographical localization, etc...)

Related Information

• Primary Sponsor: Eto Takashi
• Secondary ID(s): NCT04906005