Safety, Tolerability and Pharmacokinetics of Genz-682452 in Healthy Men

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Single Oral Doses of Genz-682452 With a Pilot Investigation of Food Effect in Healthy Adult Male Subjects.

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Genz-682452
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight between 50.0 and 100.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m^2, inclusive. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). Exclusion Criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness. Frequent headaches and/or migraine, recurrent nausea and/or vomiting. Blood donation, greater than 100 mL, within 2 months before inclusion. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. History or presence of drug or alcohol abuse. Unable to stop smoking cigarettes during the study. Excessive consumption of beverages containing xanthine bases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 (GZFD00111/TDU12766): Genz-682452<br>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. | Drug: Genz-682452<br>* Capsules for oral administration.<br>|
| Placebo Comparator: Part 1 (GZFD00111/TDU12766): Placebo<br>Participants will receive a single oral dose of placebo. | Drug: Placebo<br>* Placebo to Genz-682452<br>|
| Experimental: Part 2 (GZFD00211/FED12767): Genz-682452<br>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. | Drug: Genz-682452<br>* Capsules for oral administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Pharmacokinetics Plasma Parameters for Part 2 as measured by Cmax, tmax, tlag, AUC last, AUC, t1/2z |  | Day 1 to Day 3 |