Phase 1
N=48
Cardiac Safety Evaluation of P03277
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT03657264 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF) — 0.97; 5.05; 0.24; -0.11 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- P03277 0.1 mmol/kg (Drug); Moxifloxacin 400mg (Drug); NaCl 0.9% (Drug); P03277 0.3 mmol/kg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF) |
0.97; 5.05; 0.24; -0.11; 1.34; -0.59 | — |
| SECONDARY Change-from-baseline Mean Effect of Moxifloxacin on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF) |
1.73; -2.89; 6.13; -3.27; 8.60; -1.95 | — |
| SECONDARY Predicted Value of ∆∆QTc at Cmax |
0.41; 2.23 | — |
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 clinical dose) and 0.3 mmol/kg (supra-clinical dose) by evaluating the QT and QTc intervals.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT03657264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.