Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2017-08-21
2018-06-07
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
TRIPLE
Study Groups
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Sequence 1
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).
P03277 0.1 mmol/kg
Single intravenous bolus injection at 2 mL/sec
Moxifloxacin 400mg
One tablet per os
NaCl 0.9%
Single intravenous bolus injection at 2 mL/sec
P03277 0.3 mmol/kg
Single intravenous bolus injection at 2 mL/sec
Sequence 2
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).
P03277 0.1 mmol/kg
Single intravenous bolus injection at 2 mL/sec
Moxifloxacin 400mg
One tablet per os
NaCl 0.9%
Single intravenous bolus injection at 2 mL/sec
P03277 0.3 mmol/kg
Single intravenous bolus injection at 2 mL/sec
Sequence 3
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).
P03277 0.1 mmol/kg
Single intravenous bolus injection at 2 mL/sec
Moxifloxacin 400mg
One tablet per os
NaCl 0.9%
Single intravenous bolus injection at 2 mL/sec
P03277 0.3 mmol/kg
Single intravenous bolus injection at 2 mL/sec
Sequence 4
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).
P03277 0.1 mmol/kg
Single intravenous bolus injection at 2 mL/sec
Moxifloxacin 400mg
One tablet per os
NaCl 0.9%
Single intravenous bolus injection at 2 mL/sec
P03277 0.3 mmol/kg
Single intravenous bolus injection at 2 mL/sec
Interventions
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P03277 0.1 mmol/kg
Single intravenous bolus injection at 2 mL/sec
Moxifloxacin 400mg
One tablet per os
NaCl 0.9%
Single intravenous bolus injection at 2 mL/sec
P03277 0.3 mmol/kg
Single intravenous bolus injection at 2 mL/sec
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
59 Years
ALL
Yes
Sponsors
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Guerbet
INDUSTRY
Responsible Party
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Principal Investigators
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Frederic Vanhoutte, MD
Role: PRINCIPAL_INVESTIGATOR
SGS Clinical Pharmacology Unit
Locations
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Clinical Pharmacology unit, SGS-Life Science Service
Antwerp, , Belgium
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GDX-44-006
Identifier Type: -
Identifier Source: org_study_id
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