Status:
COMPLETED
A Study to Evaluate Pharmacokinetic Parameters and Safety of Eliglustat Absorption Through the Mouth
Lead Sponsor:
Sanofi
Conditions:
Gaucher's Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 25 2014
Trial Type :
INTERVENTIONAL
End Date :
September 21 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06193304
Start Date
August 25 2014
End Date
September 21 2014
Last Update
January 5 2024
Active Locations (1)
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1
Covance Clinical Researsh Unit
Evansville, Indiana, United States, 47710