ACY-7 Oral Administration of Acyline

This study has been completed.
Sponsor:
Collaborator:
Merrion Pharmaceuticals, LLC
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00603187
First received: January 15, 2008
Last updated: May 10, 2011
Last verified: May 2011
Results First Received: January 10, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy
Intervention: Drug: Acyline

  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
Subjects were recruited via fliers on the University of Washington campus.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Healthy, non-smoking male subjects between 18-50 years of age were recruited. Health was determined by physical exam, medical history intake and laboratory blood tests.

Reporting Groups
  Description
Oral Acyline 20 mg dose of GIPET enhanced oral acyline for 7 days

Participant Flow:   Overall Study
    Oral Acyline  
STARTED     4  
COMPLETED     4  
NOT COMPLETED     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
Oral Acyline 20 mg dose of GIPET enhanced oral acyline for 7 days

Baseline Measures
    Oral Acyline  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  40  ± 11  
Gender  
[units: participants]
 
Female     0  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures
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1.  Primary:   Testosterone Blood Serum Concentration   [ Time Frame: 7 days ]

2.  Secondary:   FSH Blood Serum Concentration   [ Time Frame: 7 days ]

3.  Secondary:   LH Blood Serum Concentration   [ Time Frame: 7 days ]


  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: Dr. John K. Amory
Organization: University of Washington
phone: 206.616.1727
e-mail: jamory@u.washington.edu


Publications:


Responsible Party: John K Amory, MD, MPH, University of Washington
ClinicalTrials.gov Identifier: NCT00603187     History of Changes
Other Study ID Numbers: 32716-W, 07-7973-W
Study First Received: January 15, 2008
Results First Received: January 10, 2011
Last Updated: May 10, 2011
Health Authority: United States: Food and Drug Administration