A Phase 1 interventional study of Oral Testosterone and Acyline in Healthy, sponsored by University of Washington. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-06.
Sponsored by University of Washington · Phase 1, Interventional, and Health services research
The purpose of this study is to test how the body absorbs a new form of oral testosterone (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at the University of Washington to monitor blood testosterone levels over a 24-hour period.
We will administer two experimental drugs, acyline and oral testosterone. Acyline shots will be given on Day 0 to turn off the body's testosterone production for about 10-14 days.
The next day, Day 1, subjects begin taking 300 mg modified slow-release testosterone pill by mouth, three times a day, around 9 AM, 1 PM, and 7 PM for a total of 27 pills.
There are overnight stays on Day 1 and Day 9 to allow monitoring of blood testosterone levels over a 24 hour period, from @9 AM to 9 AM the next morning. At those visits, blood is drawn at baseline (before taking the pill) and at 1, 2, 4, 5, 6, 8, 10, 11, 12, 14, 16, and 24 hours after the morning dose.
Acyline is an experimental drug. The FDA allows its use only in research with a small number of volunteers. We have used acyline in over 125 men without serious side effects. The use of testosterone in this study is experimental and there may be unknown or unanticipated risks.
University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA:
Drug: Oral Testosterone · Drug: Acyline
Oral Testosterone: 300 mg, pills, three times daily Day 1 - 10 (total of 27 pills)
300 ug/kg injection on Day 0
Maximum Testosterone Concentration
initial pharmacokinetics \[PK\] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment
Time frame: baseline & day 9
Mean Testosterone Concentration
initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment
Time frame: baseline & day 9
Maximum Dihydrotestosterone (DHT) Concentration
Time frame: baseline & day 9
Mean Dihydrotestosterone (DHT) Concentration
Time frame: baseline & day 9
Maximum Sex Hormone-Binding Globulin (SHGB)Concentration
Time frame: baseline & day 9
Mean SHGB Concentration
Time frame: baseline & day 9
Maximum Estradiol Concentration
Time frame: baseline & day 9
Mean Estradiol Concentration
Time frame: baseline & day 9
Free T Maximum Concentration
Free T normal range 4.7-18 ng/dL
Time frame: baseline & day 9
Free Testosterone Mean Concentration
Free T normal range 4.7-18 ng/dL
Time frame: baseline & day 9
Subjects were recruited through news media (website)and college campus bulletin boards in Seattle, WA. between July-September 2010. All visits were at the University of Washington, Seattle, WA.
| Milestone | Acyline and 0ral Testosterone |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
initial pharmacokinetics \[PK\] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment
| ng/dL | Acyline and 300 mg Oral Testosterone |
|---|---|
| Day 1 | 924 ± 44 |
| Day 9 | 741 ± 71 |
initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment
| ng/dL | Acyine and 300 mg Oral Testosterone |
|---|---|
| Day 1 | 378 ± 45 |
| Day 9 | 315 ± 41 |
| ng/dL | 300 mg Oral Testosterone |
|---|---|
| Day 1 | 233 ± 49 |
| Day 9 | 142 ± 55 |
| ng/dL | Acyline and 300 mg Oral Testosterone |
|---|---|
| Day 1 | 96 ± 38 |
| Day 9 | 69 ± 41 |
| ng/dL | 300 mg Oral Testosterone |
|---|---|
| Day 1 | 31 ± 48 |
| Day 9 | 22 ± 48 |
| ng/dL | 300 mg Oral Testosterone |
|---|---|
| Day 1 | 27 ± 46 |
| Day 9 | 19 ± 14 |
| ng/dL | 300 mg Oral Testosterone |
|---|---|
| Day 1 | 14 ± 28 |
| Day 9 | 9 ± 27 |
| ng/dL | 300 mg Oral Testosterone |
|---|---|
| Day 1 | 11 ± 18 |
| Day 9 | 7 ± 18 |
Free T normal range 4.7-18 ng/dL
| ng/dL | 300 mg Oral Testosterone |
|---|---|
| Day 1-2 | 24 ± 47 |
| Day 9-10 | 21 ± 86 |
Free T normal range 4.7-18 ng/dL
| ng/dL | 300 mg Oral Testosterone |
|---|---|
| Day 1-2 | 8.7 ± 43 |
| Day 9-10 | 8.3 ± 37 |
Collected over 4 months, July - October 2010. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acyline and Oral Testosterone | — | 0/12 (0%) | 8/12 (66.7%) |
| Event | Acyline and Oral Testosterone |
|---|---|
| upper respiratory infectionInfections and infestations | 2/12 |
| musculoskeletal injuryMusculoskeletal and connective tissue disorders | 2/12 |
| hypogonadal symptomsEndocrine disorders | 1/12 |
| HeadacheGeneral disorders | 1/12 |
| confusionGeneral disorders | 1/12 |
| elevated serum aspartate aminotrasferaseInvestigations | 1/12 |
| elevated serum alanine aminotransferaseInvestigations | 1/12 |
| elevated serum bilirubinInvestigations | 1/12 |
| Age Continuous(years) | Acyline and Oral Testosterone |
|---|---|
| Median | 28.1 (19 to 51) |
| Sex: Female, Male(Participants) | Acyline and Oral Testosterone |
|---|---|
| Female | 0 |
| Male | 12 |
| Region of Enrollment(participants) | Acyline and Oral Testosterone |
|---|---|
| United States | 12 |
| Body Mass Index (BMI)(kg/m^2) | Acyline and Oral Testosterone |
|---|---|
| Mean | 24.2 ± 1.5 |
| Body Weight(kg) | Acyline and Oral Testosterone |
|---|---|
| Mean | 79.9 ± 7.5 |
| Follicle-stimulating hormone (FSH)(IU/L) | Acyline and Oral Testosterone |
|---|---|
| Mean | 3.2 ± 1.5 |
| Luteinizing hormone (LH)(IU/L) | Acyline and Oral Testosterone |
|---|---|
| Mean | 5.4 ± 4.4 |
| Testosterone(ng/dL) | Acyline and Oral Testosterone |
|---|---|
| Mean | 510 ± 13 |
1 further baseline measures are reported on the registry.
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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