Microdose (i.v.) and oral potential therapeutic dose administration of S 47445 to assess absolute bioavailability and pharmacokinetic parameters of S 47445 in healthy young male volunteers. An open label 1 period study.

Microdose (i.v.) and oral potential therapeutic dose administration of S 47445 to assess absolute bioavailability and pharmacokinetic parameters of S 47445 in healthy young male volunteers. An open label 1 period study. - S 47445 microdose and oral therapeutic dose study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34318

Enrollment

Registered

2010-11-04

Start date

2010-11-09

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Alzheimer's Disease

Interventions

Active substance S47445 and [14C]- S47445

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male volunteers Age : 18-45 yrs BMI : 19.0-28.0 kg/m2

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, cancer or HIV/Aids. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters blood in the 10 months preceding the start of the study.

Design outcomes

Primary

Measure	Time frame
plasma and urine S 47445 concentrations, pharmacokinetic parameters. total radioactivity in plasma and urine	—

Secondary

Measure	Time frame
adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)