Safety Study of CTS21166 to Treat Alzheimer Disease - Full Text View

Sponsored by:	CoMentis
Information provided by:	CoMentis
ClinicalTrials.gov Identifier:	NCT00621010

Purpose

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

Condition	Intervention	Phase
Alzheimer's Disease	Drug: CTS21166 (ZPQ-21166)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	A Phase 1 Single Escalating Dose Study to Assess the Safety and Pharmacokinetics of CTS21166 Administered Intravenously to Healthy Adult Males

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by CoMentis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	56
Study Start Date:	June 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort: Experimental	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

Arms

Assigned Interventions

Cohort: Experimental

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

Eligibility

Ages Eligible for Study:	22 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621010

Locations

United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106

Sponsors and Collaborators

CoMentis

Investigators

Study Director:

Henry Hsu, M.D.

CoMentis

More Information

No publications provided

Responsible Party:	Comentis, Inc. ( Henry Hsu, MD )
Study ID Numbers:	CTS21166-101
Study First Received:	February 11, 2008
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00621010 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Healthy

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on September 04, 2009