ASCENDING SINGLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACO-DYNAMICS OF SRA-444 ADMINISTERED ORALLY TO HEALTHY ADULT SUBJECTS

ASCENDING SINGLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACO-DYNAMICS OF SRA-444 ADMINISTERED ORALLY TO HEALTHY ADULT SUBJECTS - Clinical Trial Protocol 3197A1-100-EU

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30387

Enrollment

Registered

2006-12-18

Start date

2007-02-03

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

Dementia neurological disorder

Interventions

Single oral doses of SRA-444 ranging from 0.5 mg to 40 mg will be evaluated in healthy adult subjects after an overnight fast of at least 10 hours. The following doses will be studied sequentially i

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: zie beneden

Exclusion criteria

Exclusion criteria: zie beneden

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of ascending single oral doses of SRA-444 in healthy adult subjects.	—

Secondary

Measure	Time frame
To obtain preliminary PK and PD profiles of SRA-444 in healthy adult subjects. To evaluate the effect of a high-fat meal on the PK of SRA-444 administered to healthy adult subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)