Healthy VolunteersPhase 1NCT03657264
Cardiac Safety Evaluation of P03277
A Phase 1 study testing P03277 0.1 mmol/kg, Moxifloxacin 400mg and NaCl 0.9% in people with Healthy Volunteers, run by Guerbet at 1 site in Belgium.
Trial summary
The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled and Open-label Positive-controlled (moxifloxacin) in healthy volunteers. The primary objective is to assess the cardiac safety after administration of P03277 to 48 healthy volunteers at dose of 0.1 mmol/kg (anticipated… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- P03277 0.1 mmol/kg, Moxifloxacin 400mg and NaCl 0.9%
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Aug 2017to 7 Jun 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject assessed as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
- Subject with a Body Mass Index (BMI) > 19 kg/m² and < 28 kg/m² and a weight at least of 40 kg for female and 50 kg for male and at maximum of 100 kg
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Clinical Pharmacology unit, SGS-Life Science Service
Antwerp, 2060
About this study
Official title: Thorough QT/QTc Study to Assess the Electrocardiographic Safety of a New Gadolinium-based Contrast Agent P03277 in Healthy Volunteers
The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled and Open-label Positive-controlled (moxifloxacin) in healthy volunteers.
The primary objective is to assess the cardiac safety after administration of P03277 to 48 healthy volunteers at dose of 0.1 mmol/kg (anticipated clinical dose) and 0.3 mmol/kg (supra-clinical dose) by evaluating the QT and QTc intervals.
Read the detailed description
Each subjects will be administered with 4 products (P03277 at the 2 different doses, placebo and moxifloxacin) in a 4*4 cross over sequence balanced for first order carry over effect. Twelve subjects will be assigned to each sequence (6 males and 6 females). The volunteers will be enrolled sequentially by cohort of 8 subjects.
ECG measurements will be compared with ECG parameters collected after administration of placebo (Nacl 0.9%). The test sensitivity will be assessed using a positive control (moxifloxacin 400 mg per os) known to induce delays in QT intervals.
- Conditions
- Healthy Volunteers
- Being tested
- P03277 0.1 mmol/kg, Moxifloxacin 400mg, NaCl 0.9%, P03277 0.3 mmol/kg
- Keywords
- Gadolinium-based contrast agent, Cardiac safety, ECG, Gadopiclenol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P03277 0.1 mmol/kgDrug
Also called Gadopiclenol
Single intravenous bolus injection at 2 mL/sec
Moxifloxacin 400mgDrug
One tablet per os
NaCl 0.9%Drug
Single intravenous bolus injection at 2 mL/sec
P03277 0.3 mmol/kgDrug
Also called Gadopiclenol
Single intravenous bolus injection at 2 mL/sec
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | The sequence of administration is: P/ScD/PC/CD
Where:
* P = Placebo (Nacl 0.9%)
* CD = P03277 tested at 0.1 mmol/kg
* ScD = P03277 tested at 0.3 mmol/kg
* PC = Positive control (moxifloxacin 400 mg - per os). Receives: Drug: P03277 0.1 mmol/kg; Drug: Moxifloxacin 400mg; Drug: NaCl 0.9%; Drug: P03277 0.3 mmol/kg |
| Sequence 2 | Experimental | The sequence of administration is: CD/PC/ScD/P
Where:
* P = Placebo (Nacl 0.9%)
* CD = P03277 tested at 0.1 mmol/kg
* ScD = P03277 tested at 0.3 mmol/kg
* PC = Positive control (moxifloxacin 400 mg - per os). Receives: Drug: P03277 0.1 mmol/kg; Drug: Moxifloxacin 400mg; Drug: NaCl 0.9%; Drug: P03277 0.3 mmol/kg |
| Sequence 3 | Experimental | The sequence of administration is: ScD/CD/P/PC
Where:
* P = Placebo (Nacl 0.9%)
* CD = P03277 tested at 0.1 mmol/kg
* ScD = P03277 tested at 0.3 mmol/kg
* PC = Positive control (moxifloxacin 400 mg - per os). Receives: Drug: P03277 0.1 mmol/kg; Drug: Moxifloxacin 400mg; Drug: NaCl 0.9%; Drug: P03277 0.3 mmol/kg |
| Sequence 4 | Experimental | The sequence of administration is: PC/P/CD/ScD
Where:
* P = Placebo (Nacl 0.9%)
* CD = P03277 tested at 0.1 mmol/kg
* ScD = P03277 tested at 0.3 mmol/kg
* PC = Positive control (moxifloxacin 400 mg - per os). Receives: Drug: P03277 0.1 mmol/kg; Drug: Moxifloxacin 400mg; Drug: NaCl 0.9%; Drug: P03277 0.3 mmol/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
Each subject was monitored with a 12-lead Holter electrocardiogram (ECG). The study had to show that both 0.1 and 0.3 mmol/kg doses of P03277 do not increase the QT interval corrected by Fridericia formula (QTcF).
The study is successful if the difference between each of the two doses of P03277 and placebo for the largest mean change from baseline for the QTcF is lower than 10 milliseconds. The baseline was defined as the mean of the 3 triplicates ECG measured within 1 hour before each product administration.
Measured: from 1 hour before any administration until 24 hours post-administration at the following timepoints: -1 hour, 5 min, 10 min, 20 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours.
Secondary outcomes (2)
Change-from-baseline Mean Effect of Moxifloxacin on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
Each subject was monitored with a 12-lead Holter electrocardiogram (ECG). The assay sensitivity was assessed through this outcome. The difference between the positive control (moxifloxacin) and placebo for the largest mean change from baseline for the QTcF had to be greater than 5 milliseconds for at least one time point. The baseline was defined as the mean of the 3 triplicates ECG measured within 1 hour before each product administration.
Measured: from 1 hour before any administration until 4 hours post-administration at the following timepoints: -1 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours.
Predicted Value of ∆∆QTc at Cmax
Concentration-response relationship was investigated between ∆QTc and P03277 concentrations using a mixed model approach. Plasma concentration of P03277 was measured at the same timepoints as ECG measurements.
Measured: from 1 hour before any administration until 24 hours post-administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start21 Aug 2017
- Primary completion7 Jun 2018
- Study completion7 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Williams design for a 4\*4 cross over
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederic Vanhoutte, MD, Principal investigator, SGS Clinical Pharmacology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657264
- Sponsor's protocol ID
- GDX-44-006
- Status last verified
- Mar 2022
- First submitted
- 31 Aug 2018
- Last updated
- 18 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thorough QT/QTc Study to Assess the Electrocardiographic Safety of a New Gadolinium-based Contrast Agent P03277 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03657264
- Acronym / sponsor ID
- GDX-44-006
- Conditions
- Healthy Volunteers
- Keywords
- Gadolinium-based contrast agent, Cardiac safety, ECG, Gadopiclenol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Posted 22 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled and Open-label Positive-controlled (moxifloxacin) in healthy volunteers.
The primary objective is to assess the cardiac safety after administration of P03277 to 48 healthy volunteers at dose of 0.1 mmol/kg (anticipated clinical dose) and 0.3 mmol/kg (supra-clinical dose) by evaluating the QT and QTc intervals.
Detailed description
Each subjects will be administered with 4 products (P03277 at the 2 different doses, placebo and moxifloxacin) in a 4*4 cross over sequence balanced for first order carry over effect. Twelve subjects will be assigned to each sequence (6 males and 6 females). The volunteers will be enrolled sequentially by cohort of 8 subjects.
ECG measurements will be compared with ECG parameters collected after administration of placebo (Nacl 0.9%). The test sensitivity will be assessed using a positive control (moxifloxacin 400 mg per os) known to induce delays in QT intervals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Williams design for a 4*4 cross over
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: P03277 0.1 mmol/kg, Drug: Moxifloxacin 400mg, Drug: NaCl 0.9%, Drug: P03277 0.3 mmol/kgThe sequence of administration is: P/ScD/PC/CD Where: * P = Placebo (Nacl 0.9%) * CD = P03277 tested at 0.1 mmol/kg * ScD = P03277 tested at 0.3 mmol/kg * PC = Positive control (moxifloxacin 400 mg - per os). |
| Sequence 2 | Experimental | Drug: P03277 0.1 mmol/kg, Drug: Moxifloxacin 400mg, Drug: NaCl 0.9%, Drug: P03277 0.3 mmol/kgThe sequence of administration is: CD/PC/ScD/P Where: * P = Placebo (Nacl 0.9%) * CD = P03277 tested at 0.1 mmol/kg * ScD = P03277 tested at 0.3 mmol/kg * PC = Positive control (moxifloxacin 400 mg - per os). |
| Sequence 3 | Experimental | Drug: P03277 0.1 mmol/kg, Drug: Moxifloxacin 400mg, Drug: NaCl 0.9%, Drug: P03277 0.3 mmol/kgThe sequence of administration is: ScD/CD/P/PC Where: * P = Placebo (Nacl 0.9%) * CD = P03277 tested at 0.1 mmol/kg * ScD = P03277 tested at 0.3 mmol/kg * PC = Positive control (moxifloxacin 400 mg - per os). |
| Sequence 4 | Experimental | Drug: P03277 0.1 mmol/kg, Drug: Moxifloxacin 400mg, Drug: NaCl 0.9%, Drug: P03277 0.3 mmol/kgThe sequence of administration is: PC/P/CD/ScD Where: * P = Placebo (Nacl 0.9%) * CD = P03277 tested at 0.1 mmol/kg * ScD = P03277 tested at 0.3 mmol/kg * PC = Positive control (moxifloxacin 400 mg - per os). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subject assessed as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
- Subject with a Body Mass Index (BMI) > 19 kg/m² and < 28 kg/m² and a weight at least of 40 kg for female and 50 kg for male and at maximum of 100 kg
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| P03277 0.1 mmol/kgAlso: GadopiclenolSingle intravenous bolus injection at 2 mL/sec | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Moxifloxacin 400mgOne tablet per os | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| NaCl 0.9%Single intravenous bolus injection at 2 mL/sec | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| P03277 0.3 mmol/kgAlso: GadopiclenolSingle intravenous bolus injection at 2 mL/sec | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
Time frame: from 1 hour before any administration until 24 hours post-administration at the following timepoints: -1 hour, 5 min, 10 min, 20 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours.
Each subject was monitored with a 12-lead Holter electrocardiogram (ECG). The study had to show that both 0.1 and 0.3 mmol/kg doses of P03277 do not increase the QT interval corrected by Fridericia formula (QTcF). The study is successful if the difference between each of the two doses of P03277 and placebo for the largest mean change from baseline for the QTcF is lower than 10 milliseconds. The baseline was defined as the mean of the 3 triplicates ECG measured within 1 hour before each product administration.
2 secondary outcomes
Change-from-baseline Mean Effect of Moxifloxacin on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)
Time frame: from 1 hour before any administration until 4 hours post-administration at the following timepoints: -1 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours.
Predicted Value of ∆∆QTc at Cmax
Time frame: from 1 hour before any administration until 24 hours post-administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Frederic Vanhoutte, MD principal investigator
SGS Clinical Pharmacology Unit
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 P03277 0.1 mmol/kg, Moxifloxacin 400mg and NaCl 0.9% in people with Healthy Volunteers, run by Guerbet at 1 site in Belgium.
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 1 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 18 Jul 2022. 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 Belgium. 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. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF) (time frame: from 1 hour before any administration until 24 hours post-administration at the following timepoints: -1 hour, 5 min, 10 min, 20 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours.). 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 18 Jul 2022.