Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by:
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00490945
First received: June 22, 2007
Last updated: August 8, 2014
Last verified: August 2014
Results First Received: February 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Circadian Rhythm Sleep Disorders
Intervention: Drug: VEC-162

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Number of Enrolled Subjects = 45 Number of Enrollment Failures = 6

Reporting Groups
  Description
Placebo Randomized to Placebo
10 mg VEC-162 Randomized to 10 mg VEC-162
20 mg VEC-162 Randomized to 20 mg VEC-162
50 mg VEC-162 Randomized to 50 mg VEC-162
100 mg VEC-162 Randomized to 100 mg VEC-162

Participant Flow:   Overall Study
    Placebo     10 mg VEC-162     20 mg VEC-162     50 mg VEC-162     100 mg VEC-162  
STARTED     8     9     8     7     7  
COMPLETED     8     8     8     7     7  
NOT COMPLETED     0     1     0     0     0  
Adverse Event                 0                 1                 0                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Randomized to Placebo
10 mg VEC-162 Randomized to 10 mg VEC-162
20 mg VEC-162 Randomized to 20 mg VEC-162
50 mg VEC-162 Randomized to 50 mg VEC-162
100 mg VEC-162 Randomized to 100 mg VEC-162
Total Total of all reporting groups

Baseline Measures
    Placebo     10 mg VEC-162     20 mg VEC-162     50 mg VEC-162     100 mg VEC-162     Total  
Number of Participants  
[units: participants]
  8     9     8     7     7     39  
Age  
[units: years]
Mean ± Standard Deviation
  27.5  ± 6.7     31.8  ± 7.4     32.5  ± 9.6     27.4  ± 6.2     30.4  ± 9.5     30.0  ± 7.9  
Gender  
[units: participants]
           
Female     5     3     4     4     4     20  
Male     3     6     4     3     3     19  



  Outcome Measures
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1.  Primary:   Circadian Phase Shift   [ Time Frame: Night 3 and Night 4 ]

2.  Primary:   Mean Sleep Efficiency   [ Time Frame: Night 4 and Night 2 ]

3.  Secondary:   Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS)   [ Time Frame: Night 2 and Night 4 ]

4.  Secondary:   VEC-162 AUC   [ Time Frame: Night 4 ]

5.  Secondary:   VEC-162 Cmax   [ Time Frame: Night 4 ]

6.  Secondary:   VEC-162 Tmax   [ Time Frame: Night 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marlene Dressman, Ph.D.
Organization: Vanda Pharmaceuticals Inc.
phone: 202-734-3462
e-mail: marelene.dressman@vandapharma.com


No publications provided by Vanda Pharmaceuticals

Publications automatically indexed to this study:

ClinicalTrials.gov Identifier: NCT00490945     History of Changes
Other Study ID Numbers: VP-VEC-162-2101
Study First Received: June 22, 2007
Results First Received: February 28, 2014
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration