Gaucher's Disease
Conditions
Brief summary
A study to assess the absorption of eliglustat through the mouth in healthy subjects and the safety of any systemic exposure resulting from oral surface absorption of eliglustat in healthy subjects.
Detailed description
Duration of the study for each subject, not including screening, will be 3 days including follow-up.
Interventions
DRUGEliglustat
Pharmaceutical form:solution -Route of administration: Oral wihtout ingestion
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Body weight between 50.0 and 100.0 kg, inclusive, for males, and between 40.0 and 90.0 kg, inclusive, for females, body mass index between 18.0 and 30.0 kg/m2, inclusive. Having given written informed consent prior to undertaking any study-related procedure. Certified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination, laboratory parameters, and ecg).
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma pharmacokinetic (PK) parameter AUC 2-4h | Multiple timepoints on Day 1 | Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 2 hours post dose to 4 hours post dose (AUC2-4h) |
| Plasma pharmacokinetic (PK) parameter AUC 4-6h | Multiple timepoints on Day 1 | Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 4 hours post dose to 6 hours post dose (AUC4-6h) |
| Plasma pharmacokinetic (PK) parameter tlast | Multiple timepoints on Day 1 | — |
| Plasma pharmacokinetic (PK) parameter: Cmax | Multiple timepoints on Day 1 | Maximum plasma concentration observed (Cmax) |
| Plasma pharmacokinetic (PK) parameter tmax | Multiple timepoints on Day 1 | Time to reach Cmax (tmax) |
| Plasma pharmacokinetic (PK) parameter AUClast | Multiple timepoints on Day 1 | Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast (AUClast) |
| Plasma pharmacokinetic (PK) parameter AUC 0-2h | Multiple timepoints on Day 1 | Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to 2 hours (h) post dose (AUC0-2h) |
Secondary
| Measure | Time frame |
|---|---|
| Treatment emergent adverse events during the study | Up to Day 3 |
Countries
United States
Outcome results
None listed