Randomized, double-blind, placebo-controlled study of the tolerability and pharmacokinetics of ascending single (TDU6964) and 14-day repeated (TDR6966) oral doses of SAR501788 and pilot food variability evaluation (FED6965) in healthy young male subjects - Tolerability and pharmacokinetics of 14-day repeated oral doses of SAR501788 in healthy elderly male and female subjects (TDR6967)

Completed

Conditions: neuropathies nerve pain
10034606

Registration Number: NL-OMON32736

Lead Sponsor: Sanofi-aventis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 152

Inclusion Criteria

1. Healthy male subjects, between 18 and 45 years inclusive.
2. Body weight between 50.0 and 95.0 kg inclusive, body mass index between 18.0 and 28.0 kg/m2 inclusive
10. Healthy male or post-menopausal female subjects, between 60 and 75 years of age inclusive.
11. Body weight between 50 kg and 105 kg if male, between 40 kg and 95 kg if female, body mass index between 18 and 33 kg/m2.

Exclusion Criteria

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular or infectious disease, or signs of acute illness.
2. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Criteria for evaluation<br /><br>Pharmacodynamics :plasma renin, AcSDKP and aldosterone and plasma pregnenolone,<br /><br>pregnenolone sulfate, testosterone, DHEA, DHEA sulphate and serum prolactin<br /><br>(Parts 3 and 4)<br /><br>Pharmacokinetics :plasma and urine SAR501788 concentrations, urine 6-beta-OH<br /><br>cortisol and cortisol concentration, pharmacokinetic parameters<br /><br>Safety :adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination, telemetry, oral body temperature<br /><br><br /><br>Statistical methods<br /><br>Pharmacodynamic parameters :descriptive statistics (Parts 3 and 4)<br /><br>Pharmacokinetics parameters :descriptive statistics<br /><br>Safety parameters :descriptive statistics</p><br>

Secondary Outcome Measures