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

A Double Blind, Sequential, Ascending Single Dose, Placebo-Controlled Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Study of TC-2216 in Healthy Young Male Volunteers.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: TC-2216

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rouffache, France
    • Forenap Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2	Drug: TC-2216; Multiple ascending dose groups will be explored.
PLACEBO_COMPARATOR: 1	Drug: TC-2216; Multiple ascending dose groups will be explored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hematology, biochemistry, urine analysis, vital sign, ECG, adverse events.	4 days

Secondary Outcome Measures

Outcome Measure	Time Frame
plasma and urine pharmacokinetics, Pharmaco EEG, Bond-Lader Visual Analogue Scal	4 days

Collaborators and Investigators

• Sponsor: Targacept Inc.
• Investigators: Study Director: Targacept Clinical Trials, MD, Targacept Inc.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): January 1, 2008
• Study Completion (ACTUAL): February 1, 2008

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 28, 2007
• First Posted (ESTIMATE): December 31, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): July 18, 2008
• Last Update Submitted That Met QC Criteria: July 17, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Healthy; Healthy Volunteers
• Other Study ID Numbers: TC-2216-232-CLP-001