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.
Overview
- Phase
- Phase 1
- Intervention
- Genz-682452
- Conditions
- Healthy Volunteer
- Sponsor
- Genzyme, a Sanofi Company
- Enrollment
- 63
- Primary Endpoint
- Number of participants with adverse events in Part 1
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Part 1 (GZFD00111/TDU12766): 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.
Intervention: Genz-682452
Part 1 (GZFD00111/TDU12766): Placebo
Participants will receive a single oral dose of placebo.
Intervention: Placebo
Part 2 (GZFD00211/FED12767): 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.
Intervention: Genz-682452
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(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)