Back to resultsSafety Study of CTS21166 to Treat Alzheimer Disease (CTS)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CTS21166 (ZPQ-21166)
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility 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
Sites / Locations
- Lifetree Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cohort
Arm Description
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00621010
Brief Title
Safety Study of CTS21166 to Treat Alzheimer Disease
Acronym
CTS
Official Title
A Phase 1 Single Escalating Dose Study to Assess the Safety and Pharmacokinetics of CTS21166 Administered Intravenously to Healthy Adult Males
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
CoMentis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is the first human exposure for the drug candidate CTS21166 in healthy male volunteers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CTS21166 (ZPQ-21166)
Intervention Description
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 Measure Information:
Title
To evaluate the safety and tolerability of single ascending doses of CTS21166 following intravenous administration
Secondary Outcome Measure Information:
Title
To evaluate the pharmacokinetics(PK) of CTS21166 and its major metabolites as assessed in plasma
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Hsu, M.D.
Organizational Affiliation
CoMentis
Official's Role
Study Director
Facility Information:
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of CTS21166 to Treat Alzheimer Disease
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