Trial record 2 of 2 for: alzheimer AND comentis

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Safety Study of CTS21166 to Treat Alzheimer Disease

This study has been completed.

Sponsor:

Information provided by:

CoMentis

ClinicalTrials.gov Identifier:

NCT00621010

First received: February 11, 2008

Last updated: July 7, 2008

Last verified: July 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

February 11, 2008

Last Updated Date

July 7, 2008

Start Date ^ICMJE

June 2007

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the safety and tolerability of single ascending doses of CTS21166 following intravenous administration

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00621010 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the pharmacokinetics(PK) of CTS21166 and its major metabolites as assessed in plasma

Original Secondary Outcome Measures ^ICMJE

To evaluate the pharmacokinetics of CTS21166 and its major metabolites as assessed in plasma

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety Study of CTS21166 to Treat Alzheimer Disease

Official Title ^ICMJE

A Phase 1 Single Escalating Dose Study to Assess the Safety and Pharmacokinetics of CTS21166 Administered Intravenously to Healthy Adult Males

Brief Summary

This study is the first human exposure for the drug candidate CTS21166 in healthy male volunteers

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: CTS21166 (ZPQ-21166)

Cohort 1: (7.5 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 2: (22.5 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 3: (45 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 4: (90 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 5: (150 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 6: (225 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days,proceed to Part B.

Cohort 7: (225 mg): Up to 10 subjects, open label, 3 hour infusion

Study Arm (s)

Experimental: Cohort

Intervention: Drug: CTS21166 (ZPQ-21166)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy adult male > age 21;
non-smoker (minimum 6 months);

Exclusion Criteria:

History or evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, psychiatric, oncologic, or allergic (including anaphylactic drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease
History or evidence of intravenous illicit drug use, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
Participation in another clinical trial within 30 days prior to dosing

Gender

Male

Ages

22 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00621010

Other Study ID Numbers ^ICMJE

CTS21166-101

Has Data Monitoring Committee

Yes

Responsible Party

Henry Hsu, MD, Comentis, Inc.

Study Sponsor ^ICMJE

CoMentis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Henry Hsu, M.D.

CoMentis

Information Provided By

CoMentis

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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