NCT00621010

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
Last Updated

July 9, 2008

Status Verified

July 1, 2008

Enrollment Period

8 months

First QC Date

February 11, 2008

Last Update Submit

July 7, 2008

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (1)

Cohort

EXPERIMENTAL
Drug: CTS21166 (ZPQ-21166)

Interventions

CTS21166 (ZPQ-21166)DRUG

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

Cohort

Eligibility Criteria

Age22 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult male \> age 21;
  • non-smoker (minimum 6 months);

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Henry Hsu, M.D.

    CoMentis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 22, 2008

Study Start

June 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

July 9, 2008

Record last verified: 2008-07

Locations

US(1)