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A rising multiple dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered SCH 900389 in healthy females (P07036)

A rising multiple dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered SCH 900389 in healthy females (P07036) - P07036

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36461
Enrollment
52
Registered
2010-12-23
Start date
2011-03-01
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

infertility

Interventions

The study will start with a screening. At the screening a physical examination will take place, a few other standard medical assessments will be performed (ECG, Vital signs) and standard gynecologic

Sponsors

Schering-Plough
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy female subjects

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at screening

Design outcomes

Primary

MeasureTime frame
To investigate the safety and tolerability of the test compound after multiple oral dose administration for up to14 days To investigate the pharmacodynamic effects of the test compound after multiple dose oral administration for up to 14 days

Secondary

MeasureTime frame
*To investigate the multiple dose pharmacokinetics of the test compound

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)