Excretion balance, pharmacokinetics and metabolism of S 47445 after single oral administration of 20mg [14C]-S 47445 in young healthy male volunteers.

Excretion balance, pharmacokinetics and metabolism of S 47445 after single oral administration of 20mg [14C]-S 47445 in young healthy male volunteers. - S 47445-11 ADME

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35510

Enrollment

Registered

2011-10-25

Start date

2011-11-02

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

Alzheimers disease dementia

Interventions

Single oral dose of 20 mg, 2,35MBq of [14C] S-47445 as a capsule.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Gender: male Age: 18 * 45 years, inclusive BMI: 20.0 * 28.0 kg/m2, inclusive Extensive metabolizer CYP2D6

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 donating more than 250 ml of blood in the 3 months prior the start of this study, or in case of donating more than 1.5 liter of blood in the 10 months, .

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic measurements: - Excretion balance : Determination of cumulative amount of administered [14C] drug-related material in urine and faeces after single oral administration of 20 mg - 64 µCi of [14C]-S47445. - Pharmacokinetics : Concentrations of total radioactivity will be measured in whole blood, plasma and urine. Total radioactivity exposure and its fraction excreted in urine will be calculated from its blood and plasma concentration-time profiles and its concentrations in urine. -Concentrations of S 47445 will be measured in blood and urine. Pharmacokinetic parameters of S 47445 will be calculated from their blood and plasma concentration-time profiles and its concentrations in urine Metabolism: Investigation of the metabolism profile of S 47445 in plasma, urine and faeces.	—

Measure

Time frame

Pharmacokinetic measurements: - Excretion balance : Determination of cumulative amount of administered [14C] drug-related material in urine and faeces after single oral administration of 20 mg - 64 µCi of [14C]-S47445. - Pharmacokinetics : Concentrations of total radioactivity will be measured in whole blood, plasma and urine. Total radioactivity exposure and its fraction excreted in urine will be calculated from its blood and plasma concentration-time profiles and its concentrations in urine. -Concentrations of S 47445 will be measured in blood and urine. Pharmacokinetic parameters of S 47445 will be calculated from their blood and plasma concentration-time profiles and its concentrations in urine Metabolism: Investigation of the metabolism profile of S 47445 in plasma, urine and faeces.

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Secondary

Measure	Time frame
Safety measurements: Physical examination, body weight, body temperature, blood pressure, heart rate and respiratory rate, ECG, laboratory parameters and adverse events.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)