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

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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: TC-2216 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Sequential, Ascending Single Dose, Placebo-Controlled Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Study of TC-2216 in Healthy Young Male Volunteers.
Study Start Date : January 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Placebo Comparator: 1 Drug: TC-2216
Multiple ascending dose groups will be explored.

Experimental: 2 Drug: TC-2216
Multiple ascending dose groups will be explored.

Primary Outcome Measures :
  1. hematology, biochemistry, urine analysis, vital sign, ECG, adverse events. [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. plasma and urine pharmacokinetics, Pharmaco EEG, Bond-Lader Visual Analogue Scal [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583544

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Forenap Pharma
Rouffache, France
Sponsors and Collaborators
Targacept Inc.
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Study Director: Targacept Clinical Trials, MD Targacept Inc.
Additional Information:
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Responsible Party: Geoffrey Dunbar, Vice President, CDRA, Targacept, Inc
ClinicalTrials.gov Identifier: NCT00583544    
Other Study ID Numbers: TC-2216-232-CLP-001
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: July 18, 2008
Last Verified: July 2008
Keywords provided by Targacept Inc.:
Healthy Volunteers