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

Genzyme

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: Genz-682452

Study type: Interventional

Funder types: Industry

Identifiers

NCT01674036

GZFD00111/GZFD00211

TDU12766/FED12767 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 3 patient groups, including a placebo group

Part 1 (GZFD00111/TDU12766): Genz-682452

Experimental group

Description:

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.

Treatment:

Drug: Genz-682452

Part 1 (GZFD00111/TDU12766): Placebo

Placebo Comparator group

Description:

Participants will receive a single oral dose of placebo.

Treatment:

Drug: Placebo

Part 2 (GZFD00211/FED12767): Genz-682452

Experimental group

Description:

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.

Treatment:

Drug: Genz-682452