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The primary objective is to determine the effect of repeated oral doses of eliglustat 150 mg twice daily (BID) on the pharmacokinetics (PK) of orally administered metoprolol 50 mg in healthy adults.
The secondary objective is to assess the safety and tolerability of a single oral dose of metoprolol 50 mg when administered alone and in combination with repeated oral doses of eliglustat 150 mg BID in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoprolol alone then eliglustat + metoprolol | Experimental | In Period 1 all participants will receive a single oral dose of metoprolol 50 mg on Day 1. In Period 2, participants will receive repeat oral doses of eliglustat 150 mg twice a day from Day 3 to Day 8 and a single oral dose of metoprolol 50 mg on Day 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eliglustat | Drug | Capsules for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metoprolol area under the plasma concentration time curve from time zero to the last evaluable concentration (AUC0-last) | Day 1 and Day 7; predose and up to 48 hours after drug administration | |
| Metoprolol area under the plasma concentration time curve from time zero extrapolated to infinity (AUC0-∞) | Day 1 and Day 7; Predose and up to 48 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) for metoprolol | Day 1 and Day 7; Predose and up to 48 hours after drug administration | |
| Time to maximum plasma concentration (Tmax) for metoprolol | Day 1 and Day 7; Predose and up to 48 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | United States |
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| ID | Term |
|---|---|
| C522917 | eliglustat |
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Metoprolol | Drug | Tablets for oral administration |
|
|
| Terminal elimination half-life (T1/2) for metoprolol | Day 1 and Day 7; Predose and up to 48 hours after drug administration |
| Trough plasma concentration of eliglustat | Eliglustat plasma concentration observed just prior to administration during repeated dosing. | Day 3, Day 4, Day 5, Day 6, Day 7 and Day 8. |
| Maximum plasma concentration (Cmax) of eliglustat | Day 7, up to 12 hours after drug administration |
| Time to maximum plasma concentration (Tmax) of eliglustat | Day 7; up to 12 hours after drug administration |
| Eliglustat area under the plasma concentration time curve during the dosing interval (AUC0-τ) | Day 7; up to 12 hours after drug administration |
| Number of participants with adverse events | Day 1 through to Day 14 |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |