Safety, Tolerability and Pharmacokinetics of Genz-682452 in Healthy Men
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | August 2012 |
| End Date: | September 2013 |
| Contact: | Medical Information |
| Email: | medinfo@genzyme.com |
| Phone: | 800-745-4447 |
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.
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.
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.
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