ACY-7 Oral Administration of Acyline
ACY-7
Oral Administration of the GnRH Antagonist Acyline in Normal Men Part II: Multiple-dose Pharmacokinetics (Acyline-7/MER 104-02)
2 other identifiers
interventional
4
1 country
1
Brief Summary
We propose oral dosing of gastrointestinal permeation enhancement technology \[GIPET\] enhanced oral acyline at 20 mg everyday for one week to determine the steady-state (multiple-dose) pharmacokinetics of oral acyline in four normal, healthy young men.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jan 2008
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 15, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
June 9, 2011
CompletedJune 9, 2011
May 1, 2011
1 month
January 15, 2008
January 10, 2011
May 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Testosterone Blood Serum Concentration
Blood for measurement of serum testosterone was obtained prior to the 1st, 5th and 6th dose of GIPETâ„¢-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose.
7 days
Secondary Outcomes (2)
FSH Blood Serum Concentration
7 days
LH Blood Serum Concentration
7 days
Interventions
20 mg GIPET enhanced oral dose, daily for 7-days
Eligibility Criteria
You may qualify if:
- Healthy male
- years of age
- Non-smoker
- Not taking any medications other than the study drug for the duration of the study.
- Must be willing to use an accepted method of contraception during the study.
You may not qualify if:
- BMI \> 35
- Abnormal evaluation on screening exam and labs
- Known history of alcohol abuse, illicit drugs or steroids and/or use of more that 3 alcoholic beverages/day
- History of current testosterone use or infertility
- History of testicular disease or severe testicular trauma
- History of major psychiatric disorder or sleep apnea
- History of bleeding disorder or need for anticoagulation
- Current smoker or utilizing nicotine patches or gum
- Participation in a hormonal drug study within past month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Merrion Pharmaceuticals, LLCcollaborator
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
Related Publications (7)
Herbst KL, Anawalt BD, Amory JK, Bremner WJ. Acyline: the first study in humans of a potent, new gonadotropin-releasing hormone antagonist. J Clin Endocrinol Metab. 2002 Jul;87(7):3215-20. doi: 10.1210/jcem.87.7.8675.
PMID: 12107227BACKGROUNDHerbst KL, Coviello AD, Page S, Amory JK, Anawalt BD, Bremner WJ. A single dose of the potent gonadotropin-releasing hormone antagonist acyline suppresses gonadotropins and testosterone for 2 weeks in healthy young men. J Clin Endocrinol Metab. 2004 Dec;89(12):5959-65. doi: 10.1210/jc.2003-032123.
PMID: 15579744BACKGROUNDMatthiesson KL, Amory JK, Berger R, Ugoni A, McLachlan RI, Bremner WJ. Novel male hormonal contraceptive combinations: the hormonal and spermatogenic effects of testosterone and levonorgestrel combined with a 5alpha-reductase inhibitor or gonadotropin-releasing hormone antagonist. J Clin Endocrinol Metab. 2005 Jan;90(1):91-7. doi: 10.1210/jc.2004-1228. Epub 2004 Oct 27.
PMID: 15509637BACKGROUNDAmory JK, Bremner WJ. Oral testosterone in oil plus dutasteride in men: a pharmacokinetic study. J Clin Endocrinol Metab. 2005 May;90(5):2610-7. doi: 10.1210/jc.2004-1221. Epub 2005 Feb 15.
PMID: 15713724BACKGROUNDAmory JK, Page ST, Bremner WJ. Oral testosterone in oil: pharmacokinetic effects of 5alpha reduction by finasteride or dutasteride and food intake in men. J Androl. 2006 Jan-Feb;27(1):72-8. doi: 10.2164/jandrol.05058.
PMID: 16400081BACKGROUNDPage ST, Lin DW, Mostaghel EA, Hess DL, True LD, Amory JK, Nelson PS, Matsumoto AM, Bremner WJ. Persistent intraprostatic androgen concentrations after medical castration in healthy men. J Clin Endocrinol Metab. 2006 Oct;91(10):3850-6. doi: 10.1210/jc.2006-0968. Epub 2006 Aug 1.
PMID: 16882745BACKGROUNDPage ST, Amory JK, Anawalt BD, Irwig MS, Brockenbrough AT, Matsumoto AM, Bremner WJ. Testosterone gel combined with depomedroxyprogesterone acetate is an effective male hormonal contraceptive regimen and is not enhanced by the addition of a GnRH antagonist. J Clin Endocrinol Metab. 2006 Nov;91(11):4374-80. doi: 10.1210/jc.2006-1411. Epub 2006 Aug 29.
PMID: 16940442BACKGROUND
MeSH Terms
Interventions
Results Point of Contact
- Title
- Dr. John K. Amory
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
John K Amory, MD, MPH
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 15, 2008
First Posted
January 28, 2008
Study Start
January 1, 2008
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
June 9, 2011
Results First Posted
June 9, 2011
Record last verified: 2011-05