Study in healthy recreational polydrug users to measure the Abuse Potential of TC-5214 - TC-5214
Study identifier:D4130C00022
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Single-center, Single-dose, Double-blind, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of TC-5214 in Healthy Recreational Polydrug Users
Medical condition
drug abuse, Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
TC-5214, TC-5214 Placebo, Ketamine, Phentermine
Sex
All
Actual Enrollment
0
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Jan 2012
Estimated Primary Completion Date: 01 Apr 2012
Estimated Study Completion Date: 01 Apr 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Mar 2012 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Crossover Treatment Sequence 1 Period 1: Placebo, Period 2: Phentermine 45 mg, Period 3: Phentermine 90 mg, Period 4: Ketamine 100 mg, Period 5: TC-5214 2 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 16 mg | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
| Experimental: Crossover Treatment Sequence 2 Period 1: Phentermine 45 mg, Period 2: Ketamine 100 mg , Period 3: Placebo, Period 4: TC-5214 8 mg , Period 5: Phentermine 90 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 2 mg | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
| Experimental: Crossover Treatment Sequence 3 Period 1: Ketamine 100 mg, Period 2: TC-5214 8 mg, Period 3: Phentermine 45 mg, Period 4: TC-5214 16 mg, Period 5: Placebo, Period 6: TC-5214 2 mg, Period 7: Phentermine 90 mg | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
| Experimental: Crossover Treatment Sequence 4 Period 1: TC-5214 8 mg, Period 2: TC-5214 16 mg, Period 3: Ketamine 100 mg, Period 4: TC-5214 2 mg, Period 5: Phentermine 45 mg , Period 6: Phentermine 90 mg, Period 7: Placebo | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
| Experimental: Crossover Treatment Sequence 5 Period 1: TC-5214 16 mg, Period 2: TC-5214 2 mg, Period 3: TC-5214 8 mg, Period 4: Phentermine 90 mg, Period 5: Ketamine 100 mg, Period 6: Placebo , Period 7: Phentermine 45 mg | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
| Experimental: Crossover Treatment Sequence 6 Period 1: TC-5214 2 mg, Period 2: Phentermine 90 mg, Period 3: TC-5214 16 mg, Period 4: Placebo, Period 5: TC-5214 8 mg, Period 6:Phentermine 45 mg , Period 7: Ketamine 100 mg | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
| Experimental: Crossover Treatment Sequence 7 Period 1: Phentermine 90 mg, Period 2: Placebo, Period 3: TC-5214 2 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 16 mg, Period 6: Ketamine 100 mg, Period 7: TC-5214 8 mg | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
| Experimental: Crossover Treatment Sequence 8 Period 1: TC-5214 16 mg, Period 2: TC-5214 8 mg, Period 3: TC-5214 2 mg, Period 4: Ketamine 100 mg, Period 5: Phentermine 90 mg, Period 6: Phentermine 45 mg, Period 7: Placebo | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
| Experimental: Crossover Treatment Sequence 9 Period 1: TC-5214 2 mg, Period 2: TC-5214 16 mg, Period 3: Phentermine 90 mg, Period 4: TC-5214 8 mg, Period 5: Placebo, Period 6: Ketamine 100 mg, Period 7: Phentermine 45 mg | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
| Experimental: Crossover Treatment Sequence 10 Period 1: Phentermine 90 mg, Period 2: TC-5214 2 mg, Period 3: Placebo, Period 4: TC-5214 16 mg Ketamine 100 mg, Period 5: Phentermine 45 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 2 mg | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
| Experimental: Crossover Treatment Sequence 11 Period 1: Placebo, Period 2: Phentermine 90 mg, Period 3:Phentermine 45 mg, Period 4: TC-5214 2 mg, Period 5: Ketamine 100 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 8 mg | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
| Experimental: Crossover Treatment Sequence 12 Period 1: Phentermine 45 mg, Period 2: Placebo, Period 3: Ketamine 100 mg, Period 4:Phentermine 90 mg, Period 5: TC-5214 8 mg, Period 6: TC-5214 2 mg, Period 7: TC-5214 16 mg | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
| Experimental: Crossover Treatment Sequence 13 Period 1: Ketamine 100 mg, Period 2: Phentermine 45 mg, Period 3: TC-5214 8 mg, Period 4: Placebo, Period 5: TC-5214 16 mg, Period 6: Phentermine 90 mg, Period 7: TC-5214 2 mg | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
| Experimental: Crossover Treatment Sequence 14 Period 1: TC-5214 8 mg, Period 2: Ketamine 100 mg, Period 3: TC-5214 16 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 2 mg, Period 6: Placebo, Period 7: Phentermine 90 mg | Drug: TC-5214 Single oral dose of 2 mg Drug: TC-5214 Placebo Single oral dose Drug: Ketamine Single oral dose of 100 mg Drug: Phentermine Single oral dose of 45 mg Drug: TC-5214 Single oral dose of 8 mg Drug: TC-5214 Single oral dose of 16 mg Drug: Phentermine Single oral dose of 90 mg |
Contacts
Investigators
Principal Investigator
Hans A Eriksson
AstraZeneca
Kvzmbergagatan 12,
15185,Sodertalje,
Sweden
