Skip to content

Study Evaluating the Safety and Tolerability of Single Ascending Dose (SAD) SLV-351 in Healthy Subjects

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SLV-351 Administered Orally to Healthy Subjects

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00581191
Enrollment
72
Registered
2007-12-27
Start date
2008-01-31
Completion date
2008-03-31
Last updated
2009-08-04

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

Conditions

Healthy

Keywords

SAD, Healthy

Brief summary

Safety and tolerability of single oral doses in healthy subjects.

Interventions

DRUGSLV-351

SLV-351 capsules taken once

Sponsors

Solvay Pharmaceuticals
CollaboratorINDUSTRY
Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Men, aged 18-50 years. * Women of nonchildbearing potential, aged 18-50 years.

Design outcomes

Primary

MeasureTime frame
Safet and tolerability35 days

Secondary

MeasureTime frame
PK and PD35 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026