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

Genzyme, a Sanofi Company63 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteer

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of participants with adverse events in Part 1

Time frame: Up to 4 weeks

Number of participants with adverse events in Part 2

Time frame: Up to 5 weeks

Secondary Outcomes

Pharmacokinetics Plasma Parameters for Part 1 as measured by Cmax, tmax, AUC last, AUC, t1/2z, Vss/F, CL/F

Time frame: Day 1 through Day 5

Pharmacokinetics Urine Parameters for Part 1 as measured by assessment of Genz-682452 urinary excretion, Ae0-t, fe0-t