Study Evaluating Single Ascending Doses Of ILS-920

February 2, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of ILS-920 Administered Intravenously To Healthy Adult Subjects

This is a first-in-human study of ILS-920. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ILS-920 after administration of ascending single intravenous (IV) doses to healthy adult subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women of nonchildbearing potential
  • Aged 18 to 50 years inclusive at screening.

Exclusion Criteria:

  • Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  • History of drug abuse within 1 year before study day 1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
ILS-920
Drug: ILS-920

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety based on vital sign evaluations, 12-lead ECGs, cardiac rhythm monitoring and routine lab tests.
Time Frame: 48 hours after study drug administration
48 hours after study drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics will measure the extent and rate of Absorption, Distribution, Metabolism and Excretion of the drug in the body.
Time Frame: 48 hours after study drug administration
48 hours after study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

January 21, 2009

First Posted (ESTIMATE)

January 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2010

Last Update Submitted That Met QC Criteria

February 2, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3216K1-1000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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