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| ID | Type | Description | Link |
|---|---|---|---|
| TDU12766/FED12767 | Other Identifier | Sanofi Study Number |
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The objectives of this study are to assess the tolerability, safety and pharmacokinetic parameters of Genz-682452 in healthy adult males, in two parts.
Part 1 (GZFD00111TDU12766): double-blind, randomized, placebo-controlled, sequential ascending single dose study;
Part 2 (GZFD00211FED12767): open-label, randomized, 2-sequence, 2-period, 2-treatment crossover study with a minimum wash-out period; to obtain preliminary information on the pharmacokinetics, tolerability and safety of Genz-682452 after single oral doses in fed and fasted conditions.
Subjects are not allowed to participate in more than 1 part of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (GZFD00111/TDU12766): Genz-682452 | Experimental | Participants will receive a single oral dose of Genz-682452. Six ascending single doses and an optional seventh dose under fasted conditions will be used. |
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| Part 1 (GZFD00111/TDU12766): Placebo | Placebo Comparator | Participants will receive a single oral dose of placebo. |
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| Part 2 (GZFD00211/FED12767): Genz-682452 | Experimental | Participants will receive two single doses of Genz-682452 separated by a 7-day wash-out period, one dose given under fed (standardized high-fat breakfast) and one under fasted conditions. The dose will be based on the blind review of the safety/tolerability/pharmacokinetic data of single dose level cohorts in Part 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genz-682452 | Drug | Capsules for oral administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events in Part 1 | Up to 4 weeks | |
| Number of participants with adverse events in Part 2 | Up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Plasma Parameters for Part 1 as measured by Cmax, tmax, AUC last, AUC, t1/2z, Vss/F, CL/F | Day 1 through Day 5 | |
| Pharmacokinetics Urine Parameters for Part 1 as measured by assessment of Genz-682452 urinary excretion, Ae0-t, fe0-t | Day 1 through Day 5 |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32851809 | Derived | Peterschmitt MJ, Crawford NPS, Gaemers SJM, Ji AJ, Sharma J, Pham TT. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Oral Venglustat in Healthy Volunteers. Clin Pharmacol Drug Dev. 2021 Jan;10(1):86-98. doi: 10.1002/cpdd.865. Epub 2020 Aug 26. |
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| ID | Term |
|---|---|
| C000608118 | venglustat |
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| Placebo | Drug | Placebo to Genz-682452 |
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| Pharmacokinetics Plasma Parameters for Part 2 as measured by Cmax, tmax, tlag, AUC last, AUC, t1/2z | Day 1 to Day 3 |