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A Safety and Tolerability Single Ascending Dose Study in Healthy Volunteers (SRD)

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: NCT00583544
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : July 18, 2008
Sponsor:
Information provided by:
Targacept Inc.

Tracking Information
First Submitted Date  ICMJE December 20, 2007
First Posted Date  ICMJE December 31, 2007
Last Update Posted Date July 18, 2008
Study Start Date  ICMJE January 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2007)
hematology, biochemistry, urine analysis, vital sign, ECG, adverse events. [ Time Frame: 4 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2007)
plasma and urine pharmacokinetics, Pharmaco EEG, Bond-Lader Visual Analogue Scal [ Time Frame: 4 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Tolerability Single Ascending Dose Study in Healthy Volunteers
Official Title  ICMJE A Double Blind, Sequential, Ascending Single Dose, Placebo-Controlled Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Study of TC-2216 in Healthy Young Male Volunteers.
Brief Summary Targacept, Inc. is studying TC-2216 for a potential role in the treatment of central nervous system (CNS) neurobiological disorders in anticipation of seeking an indication in depression and/or anxiety.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: TC-2216
Multiple ascending dose groups will be explored.
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: TC-2216
  • Experimental: 2
    Intervention: Drug: TC-2216
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 28, 2007)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male subjects aged 18-40 years old (both ages included).
  2. Subjects must be in good health as determined by their medical history, physical examination, psychological examination, ECG, vital signs, standard EEG and laboratory tests. A volunteer with a clinical abnormality may be included only if the Investigator or his designee considers that the abnormality will not introduce additional risk factor for the subject's health, or interfere with the study objectives.
  3. Subjects with a body mass index within the range 18-29 kg/m2 and a weight within the range of 60-90 kg.
  4. Non-smoker subjects (a cotinine test will be performed at screening and Day -1
  5. Subjects must be able to refrain from consuming xanthine containing beverages, and must refrain from intensive physical exercise during the study conduct (until the end of study visit).
  6. Subjects must have signed an informed consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions.
  7. Subjects must be affiliated with, or a beneficiary of, a French social security system.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Any clinically relevant acute or chronic diseases which could interfere with the subjects safety during the trial, or expose them to undue risk, or which could interfere with the study objectives.
  2. History or presence of gastrointestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  3. Any history of drug or other significant allergy.
  4. Likely to need any treatment (including dental care) during the study period.
  5. Donation of one or more units of blood within 90 days prior to the screening.
  6. Use of any prescription or over-the-counter medication within 14 days prior to admission on Day-1 (not including paracetamol in the range of 1gr/day). In addition any medications with central effects are prohibited for a period equal to 5 x half-life prior to admission (Day-1), should this period be longer than 14 days.
  7. Alcohol consumption > 40 g alcohol/day (1 glass (25 cl) of beer with 3° of alcohol = 7.5 g, or 1 glass (25 cl) of beer with 6° of alcohol = 15 g, or 1 glass (12.5 cl) of wine with 10° of alcohol = 12 g, or 1 glass (4cl) of aperitif with 42° of alcohol = 17 g).
  8. Positive alcotest at screening and Day -1 .
  9. Positive test result on hepatitis B surface antigen, hepatitis C antibody.
  10. Positive test result on HIV 1 and 2 serology.
  11. Excessive daily consumption of xanthines containing drinks (i.e > 500 mg/day of caffeine).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00583544
Other Study ID Numbers  ICMJE TC-2216-232-CLP-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Geoffrey Dunbar, Vice President, CDRA, Targacept, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Targacept Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Targacept Clinical Trials, MD Targacept Inc.
PRS Account Targacept Inc.
Verification Date July 2008

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