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Safety Study of CTS21166 to Treat Alzheimer Disease (CTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00621010
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : July 9, 2008
Sponsor:
Information provided by:
CoMentis

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: CTS21166 (ZPQ-21166) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Primary Purpose: Treatment
Official Title: A Phase 1 Single Escalating Dose Study to Assess the Safety and Pharmacokinetics of CTS21166 Administered Intravenously to Healthy Adult Males
Study Start Date : June 2007
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cohort 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




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of single ascending doses of CTS21166 following intravenous administration

Secondary Outcome Measures :
  1. To evaluate the pharmacokinetics(PK) of CTS21166 and its major metabolites as assessed in plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Henry Hsu, MD, Comentis, Inc.
ClinicalTrials.gov Identifier: NCT00621010     History of Changes
Other Study ID Numbers: CTS21166-101
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: July 9, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders