Microdose (intravenous and oral) and oral dose of S 47445 to assess absolute bioavailability, pharmacokinetic parameters and excretion balance of S 47445 in healthy young male volunteers.

Microdose (intravenous and oral) and oral dose of S 47445 to assess absolute bioavailability, pharmacokinetic parameters and excretion balance of S 47445 in healthy young male volunteers. - 14C-S 47445 microdosing study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36963

Enrollment

Registered

2012-08-15

Start date

2012-08-28

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Ziekte van Alzheimer Alzheimer's disease

Interventions

In period 1 the subjects will receive a single oral dose of 20 mg as 4 tablets of unlabeled S 47445 after an overnight fast (at least 10 hours) with 250 mL of water. Three hours later, you will rece

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male Caucasian subjects, non-smoking, EM for CYP2D6, 18 - 45 yrs, inclusive, 19.0 * 28.0 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, 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 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: Total radioactivity in plasma, urine and faeces Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)