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Genz-682452 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Genz-682452 | EXPERIMENTAL | This study will include three cohorts for doses of Genz-682452: Dose 1, Dose 2, Dose 3. Each cohort will include 12 participants, 9 of whom will be administered Genz-682452 and 3 will be administered placebo. |
| Placebo | PLACEBO_COMPARATOR | Placebo comparator taken by participants randomized to the placebo arm in each of the three cohorts. Each cohort will include 12 participants, 9 of whom will be administered Genz-682452 and 3 will be administered placebo. |
| 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. |
| Part 1 (GZFD00111/TDU12766): Placebo | PLACEBO_COMPARATOR | Participants will receive a single oral dose of placebo. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Genz-682452 | BIOLOGICAL | Capsules for oral administration. |
| Placebo | BIOLOGICAL | Placebo capsules matching the Genz-682452 capsules. |
Inclusion Criteria: * Body weight between 50.0 and 95.0 kg, inclusive, if male and between 40.0 and 85.0 kg inclusive, if female, body mass index between 18.0 and 30.0 kg/m\^2, inclusive. * Certified as healthy by a comprehensive clinical assessment. Exclusion Criteria: * Any history or presence ...
Genz-682452 is an investigational small molecule developed by Sanofi. It has been studied in Phase 1 clinical trials in healthy volunteers, and no therapeutic indication has been disclosed. The program includes two completed Phase 1 studies that evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics.
Genz-682452 is being developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi sponsored both Phase 1 trials of the compound, which were conducted in the United States in healthy volunteers.
Genz-682452 is in Phase 1 development. Two Phase 1 trials have been completed, and no later-stage trials are listed. The compound remains investigational and has not been approved for any indication.
Genz-682452 has been evaluated in two completed Phase 1 trials: NCT01710826, a safety, tolerability, pharmacokinetics, and pharmacodynamics study in 36 healthy volunteers, and NCT01674036, a safety, tolerability, and pharmacokinetics study in 63 healthy men. Both were conducted in the United States.
Both Phase 1 trials of Genz-682452 were randomized, double-blind, and placebo-controlled. NCT01710826 enrolled 36 healthy volunteers of any sex, while NCT01674036 enrolled 63 healthy men. Together the two completed studies enrolled 99 participants, and both assessed safety, tolerability, and pharmacokinetics.