Clinical trial NCT06188325: A Study to Evaluate Pharmacokinetic Parameters of Eliglustat in Healthy Volunteers Who Are CYP2D6 Extensive or Poor Metabolizers
Official title: A Randomized, Three-Period Crossover Study of Single and Repeated Doses for Three Different Strengths of Eliglustat in Healthy Adult, CYP2D6 Extensive and Poor Metabolizers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gaucher's Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-01-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the study is to evaluate dose proportionality and pharmacokinetics for three different dose levels of eliglustat after single and repeated administration.

Detailed description: Duration of the study for each subject will be between 42 to 79 days, including a screening period up to 28 days, 3 treatment periods of 7 days each period, a washup period of 7-10 days, and an end-of-study visit 8+/-2 days after the last administration.

Eligibility criteria: Inclusion Criteria:

* Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.
* Certified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination, laboratory parameters, electrocardiograms (ECG)).
* Having given written informed consent prior to undertaking any study-related procedure
* Having given written informed consent prior to undertaking any study-related procedure

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.

The following classes of drugs administered within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy:

* Drugs that are strong inducers of CYP3A (eg, rifampin, carbamazepine, phenobarbital,phenytoin, St. John's Wort).
* Drugs that inhibit CYP2D6 or CYP3A (eg, paroxetine, ketoconazole, fluconazole,ranitidine).
* Drugs that are substrates for P-gp (phenytoin, colchicine and dabigatran etexilate) or CYP2D6 (metoprolol, tricyclic antidepressants such as nortriptyline, amitriptyline, or imipramine, and phenothiazines such as perphenazine and chloropromazine).

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Primary outcomes:
measure: Pharmacokinetic (PK) parameter: Cmax
timeFrame: Multiple timepoints up to Day 35
measure: Pharmacokinetic (PK) parameter: tmax
timeFrame: Multiple timepoints up to Day 35
measure: Pharmacokinetic (PK) parameter: AUC0-T
timeFrame: Multiple timepoints up to Day 35
measure: Pharmacokinetic (PK) parameter: AUC
timeFrame: Multiple timepoints up to Day 35
Secondary outcomes:
measure: Pharmacokinetic (PK) parameter: AUClast
timeFrame: Multiple timepoints up to Day 35
measure: Pharmacokinetic (PK) parameter: tlast
timeFrame: Multiple timepoints up to Day 35
measure: Pharmacokinetic (PK) parameter: CL/F
timeFrame: Multiple timepoints up to Day 35
measure: Pharmacokinetic (PK) parameter: t1/2z
timeFrame: Multiple timepoints up to Day 35
measure: Pharmacokinetic (PK) parameter: Ctrough
timeFrame: Multiple timepoints up to Day 35
measure: Number of participants with treatment emergent adverse events, serious adverse events, and adverse event of special interest
timeFrame: Up to Day 42
Other outcomes:
Locations:
city: Dallas
country: United States
facility: M.D.Covance Clinical Research Unit 1341 W
state: Texas
Study officials:
References: