Safety Study of CTS21166 to Treat Alzheimer Disease

Alzheimer's Disease Clinical Trial

— CTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621010
• Other study ID #: CTS21166-101
• Status: Completed
• Phase: Phase 1
• First received: February 11, 2008
• Last updated: July 7, 2008
• Start date: June 2007
• Est. completion date: February 2008

Study information

• Verified date: July 2008
• Source: CoMentis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 22 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
United States	Lifetree Clinical Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
CoMentis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of single ascending doses of CTS21166 following intravenous administration
Secondary	To evaluate the pharmacokinetics(PK) of CTS21166 and its major metabolites as assessed in plasma