Phase 2
N=66
Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions
Healthy Volunteers · Brain Lesion
Bottom Line
View on ClinicalTrials.gov: NCT03603106 ↗Enrolled (actual)
66
Serious AEs
1.5%
Results posted
Jul 2019
Primary outcome: Primary: Pharmacokinetic (PK) Parameter Cmax — 248.7; 524.5; 698.7; 992.0 µg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- P03277 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK) Parameter Cmax |
248.7; 524.5; 698.7; 992.0; 2097.6; 3916.4 | — |
| PRIMARY PK Parameter T1/2 |
1.65; 1.50; 1.58; 1.73; 1.82; 2.09 | — |
| PRIMARY PK Parameter Cl |
91.7; 100.1; 106.4; 96.1; 101.3; 102.2 | — |
| PRIMARY PK Parameter Vd |
13203; 12945; 14312; 14351; 15922; 18487 | — |
Summary
The primary objective of this study was to evaluate the safety (clinical and biological) and pharmacokinetics (plasma and urine) profile of P03277 following single administration at ascending dose levels in healthy subjects.
Eligibility Criteria
Inclusion Criteria
- Part I: Subjects between 18 and 45 years old (inclusive), with a body mass index (BMI) of 18 to 30 kg/m² (exclusive) and in a good health.
- Part II: Patients 18 years old and older and having at least one brain lesion with a disruption of the blood brain barrier (BBB) and/or with abnormal vascularity in the brain. This/these lesion(s) must have been detected by previous imaging evaluation (Computed Tomography or MRI).
Data sourced from ClinicalTrials.gov (NCT03603106). 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.