A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Genz-682452 in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | October 2012 |
| End Date: | December 2012 |
| Contact: | Medical Information |
| Email: | medinfo@genzyme.com |
| Phone: | 800-745-4447 |
A Single-center, Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending 14-day Repeated Oral Doses of Genz-682452 in Healthy Male and Female Subjects
To assess in healthy adult subjects:
- The tolerability and safety of ascending repeated oral doses of Genz-682452.
- The pharmacokinetic parameters of Genz-682452 after ascending repeated oral doses.
- The pharmacodynamics of Genz-682452 after ascending repeated oral doses.
Inclusion Criteria:
- Body weight between 50.0 and 95.0 kg, inclusive, if male and between 40.0 and 85.0 kg
inclusive, if female, body mass index between 18.0 and 30.0 kg/m^2, inclusive.
- Certified as healthy by a comprehensive clinical assessment.
Exclusion Criteria:
- Any history or presence of clinically relevant cardiovascular, pulmonary,
gastrointestinal, hepatic, renal, metabolic, hematological, neurological,
osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or
infectious disease, or signs of acute illness.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
- Blood donation, any volume, within 2 months before inclusion.
- Symptomatic postural hypotension.
- History or presence of drug or alcohol abuse.
- Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen,
antihepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and
2 antibodies (anti-HIV1 and anti HIV2 Ab).
- Positive result on urine drug screen.
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