PharmacokineticsPhase 1NCT04906005
Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers
A Phase 1 study testing gadopiclenol in people with Pharmacokinetics, run by Guerbet at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- gadopiclenol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteJapan
- Study dates
- 10 May 2021to 27 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Pharmacokinetics
- Being tested
- gadopiclenol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gadopiclenolDrug
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| gadopiclenol | Experimental | Dose per administration: dose/volume of gadopiclenol to be administered will be calculated based on patient's weight at the dose of 0.025; 0.05 or 0.1 mmol/kg BW (depending on each group).
6 volunteers will receive gadopiclenol per group Receives: Drug: gadopiclenol |
| Placebo | Placebo comparator | Dose per administration: similar dose (Volume/weight) as the one used for Gadopiclenol in the considered group.
3 volunteers will receive gadopiclenol per group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum concentrations measured, value taken directly from the observed concentration-time profiles
Measured: from baseline (30 minutes before injection) to 24hours post injection
Tmax
Time corresponding to Cmax
Measured: from baseline (30 minutes before injection) to 24hours post injection
AUC 0-inf
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)
Measured: from baseline (30 minutes before injection) to 24hours post injection
t 1/2β
Terminal elimination half-life of gadopiclenol calculated as follows:
t 1/2β = ln 2 / β
Measured: from baseline (30 minutes before injection) to 24hours post injection
AUC extrap%
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:
Measured: from baseline(30 minutes before injection) to 24hours post injection
CLT
Total Clearance, calculated as CLT = Dose /AUC 0-inf
Measured: from baseline (30 minutes before injection) to 24hours post injection
Vdβ
Volume of distribution, calculated as Vdβ = Dose / (AUC 0-inf x β)
Measured: from baseline (30 min before injection) to 24h post injection
Ae
Total amount of gadopiclenol excreted in urine
Measured: Before administration and during intervals 0-6hours, 6-24hours and 24-48hours after gadopiclenol administration
CLR
Renal clearance, calculated as CLR = Ae / AUC 0-inf
Measured: Before administration and during intervals0-6hours, 6-24hours and 24-48hours after gadopiclenol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start10 May 2021
- Primary completion27 Jul 2021
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Hao, Study chair, Guerbet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906005
- Sponsor's protocol ID
- GDX-44-013
- Other IDs
- jRCT2071210029
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04906005
- Acronym / sponsor ID
- GDX-44-013
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gadopiclenol | Experimental | Drug: gadopiclenolDose per administration: dose/volume of gadopiclenol to be administered will be calculated based on patient's weight at the dose of 0.025; 0.05 or 0.1 mmol/kg BW (depending on each group). 6 volunteers will receive gadopiclenol per group |
| Placebo | Placebo comparator | Drug: PlaceboDose per administration: similar dose (Volume/weight) as the one used for Gadopiclenol in the considered group. 3 volunteers will receive gadopiclenol per group |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gadopiclenoladministration 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 | Drug | gadopiclenol |
| Placebointravenous (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 | Drug | Placebo |
Primary outcome
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
Tmax
Time frame: from baseline (30 minutes before injection) to 24hours post injection
Time corresponding to Cmax
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)
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
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:
CLT
Time frame: from baseline (30 minutes before injection) to 24hours post injection
Total Clearance, calculated as CLT = Dose /AUC 0-inf
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)
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Hao study chair
Guerbet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gadopiclenol in people with Pharmacokinetics, run by Guerbet at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: from baseline (30 minutes before injection) to 24hours post injection). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.