Trial record 2 of 2 for:    alzheimer, comentis

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

February 11, 2008
July 7, 2008
June 2007
February 2008   (final data collection date for primary outcome measure)
To evaluate the safety and tolerability of single ascending doses of CTS21166 following intravenous administration
Same as current
Complete list of historical versions of study NCT00621010 on ClinicalTrials.gov Archive Site
To evaluate the pharmacokinetics(PK) of CTS21166 and its major metabolites as assessed in plasma
To evaluate the pharmacokinetics of CTS21166 and its major metabolites as assessed in plasma
Not Provided
Not Provided
 
Safety Study of CTS21166 to Treat Alzheimer Disease
A Phase 1 Single Escalating Dose Study to Assess the Safety and Pharmacokinetics of CTS21166 Administered Intravenously to Healthy Adult Males

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Primary Purpose: Treatment
Alzheimer's Disease
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

Experimental: Cohort
Intervention: Drug: CTS21166 (ZPQ-21166)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Male
22 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00621010
CTS21166-101
Yes
Henry Hsu, MD, Comentis, Inc.
CoMentis
Not Provided
Study Director: Henry Hsu, M.D. CoMentis
CoMentis
July 2008

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