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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Placebo; Drug: Genz-682452

• Registration Number: NCT01674036
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-24
• Study First Submitted QC: 2012-08-24
• Study First Posted: 2012-08-28
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1 (GZFD00111/TDU12766): Placebo	Placebo	Participants will receive a single oral dose of placebo.
Part 1 (GZFD00111/TDU12766): Genz-682452	Genz-682452	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 2 (GZFD00211/FED12767): Genz-682452	Genz-682452	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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