NCT00420706

Brief Summary

To evaluate whether the tolerability of SCA-136 is improved by dosing with food or by increasing dose amounts in a step-wise fashion.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
Last Updated

December 10, 2007

Status Verified

December 1, 2007

First QC Date

January 8, 2007

Last Update Submit

December 6, 2007

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is the proportion of subjects reporting nausea (based on AEs) over the dosing period.

Interventions

SCA-136DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men or women, aged 18 to 50 years

You may not qualify if:

  • Abnormal vital signs, ECG, or lab results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Miami, Florida, 33126, United States

Location

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 8, 2007

First Posted

January 11, 2007

Study Start

December 1, 2006

Study Completion

December 1, 2006

Last Updated

December 10, 2007

Record last verified: 2007-12

Locations

US(1)