A Study to Evaluate Pharmacokinetic Parameters and Safety of Eliglustat Absorption Through the Mouth

Gaucher's Disease Clinical Trial

— Acronym  

Official title:

An Open-label Study to Assess the Absorption Through the Mouth After Three Repeated 50 mg Doses of Eliglustat Solution, Separated by 2-hour Intervals, Held in the Mouth for 30 Seconds With Swishing But Without Ingestion, in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06193304
• Other study ID #: PKM14187
• Secondary ID: U1111-1294-8055
• Status: Completed
• Phase: Phase 1
• Start date: August 25, 2014
• Est. completion date: September 21, 2014

Study information

• Verified date: December 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Duration of the study for each subject, not including screening, will be 3 days including follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 21, 2014
• Est. primary completion date: September 21, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gaucher Disease
• Gaucher's Disease

Intervention

Drug:
• Eliglustat
Pharmaceutical form:solution -Route of administration: Oral wihtout ingestion

Locations

Country	Name	City	State
United States	Covance Clinical Researsh Unit	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma pharmacokinetic (PK) parameter: Cmax	Maximum plasma concentration observed (Cmax)	Multiple timepoints on Day 1
Primary	Plasma pharmacokinetic (PK) parameter tmax	Time to reach Cmax (tmax)	Multiple timepoints on Day 1
Primary	Plasma pharmacokinetic (PK) parameter AUClast	Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast (AUClast)	Multiple timepoints on Day 1
Primary	Plasma pharmacokinetic (PK) parameter AUC 0-2h	Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to 2 hours (h) post dose (AUC0-2h)	Multiple timepoints on Day 1
Primary	Plasma pharmacokinetic (PK) parameter AUC 2-4h	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)	Multiple timepoints on Day 1
Primary	Plasma pharmacokinetic (PK) parameter AUC 4-6h	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)	Multiple timepoints on Day 1
Primary	Plasma pharmacokinetic (PK) parameter tlast		Multiple timepoints on Day 1
Secondary	Treatment emergent adverse events during the study		Up to Day 3