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)

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) - SAR 501788 SRD/MRD/FE/elderly study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32736

Enrollment

152

Registered

2008-06-24

Start date

2008-08-06

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuropathies nerve pain

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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).

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results