Trial Outcomes & Findings for ACY-7 Oral Administration of Acyline (NCT NCT00603187)
NCT ID: NCT00603187
Last Updated: 2011-06-09
Results Overview
Blood for measurement of serum testosterone was obtained prior to the 1st, 5th and 6th dose of GIPET™-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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
7 days
Results posted on
2011-06-09
Participant Flow
Subjects were recruited via fliers on the University of Washington campus.
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.
Participant milestones
| Measure |
Oral Acyline
20 mg dose of GIPET enhanced oral acyline for 7 days
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ACY-7 Oral Administration of Acyline
Baseline characteristics by cohort
| Measure |
Oral Acyline
n=4 Participants
20 mg dose of GIPET enhanced oral acyline for 7 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
40 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysBlood for measurement of serum testosterone was obtained prior to the 1st, 5th and 6th dose of GIPET™-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.
Outcome measures
| Measure |
Oral Acyline
n=4 Participants
20 mg dose of GIPET enhanced oral acyline for 7 days
|
|---|---|
|
Testosterone Blood Serum Concentration
pre-dose 1
|
14.25 ng/dl
Standard Deviation 4.72
|
|
Testosterone Blood Serum Concentration
pre-dose 5
|
8.53 ng/dl
Standard Deviation 2.06
|
|
Testosterone Blood Serum Concentration
pre-dose 6
|
9.83 ng/dl
Standard Deviation 1.93
|
|
Testosterone Blood Serum Concentration
pre-dose 7
|
9.83 ng/dl
Standard Deviation 3.39
|
|
Testosterone Blood Serum Concentration
dose 7, 0.5 hours
|
10.10 ng/dl
Standard Deviation 3.73
|
|
Testosterone Blood Serum Concentration
dose 7, 1 hour
|
9.50 ng/dl
Standard Deviation 3.67
|
|
Testosterone Blood Serum Concentration
dose 7, 1.5 hours
|
10.33 ng/dl
Standard Deviation 4.35
|
|
Testosterone Blood Serum Concentration
dose 7, 2 hours
|
10.65 ng/dl
Standard Deviation 3.38
|
|
Testosterone Blood Serum Concentration
dose 7, 3 hours
|
9.80 ng/dl
Standard Deviation 4.05
|
|
Testosterone Blood Serum Concentration
dose 7, 4 hours
|
8.78 ng/dl
Standard Deviation 3.18
|
|
Testosterone Blood Serum Concentration
dose 7, 6 hours
|
7.08 ng/dl
Standard Deviation 2.84
|
|
Testosterone Blood Serum Concentration
dose 7, 8 hours
|
6.80 ng/dl
Standard Deviation 3.70
|
|
Testosterone Blood Serum Concentration
dose 7, 12 hours
|
6.88 ng/dl
Standard Deviation 3.81
|
|
Testosterone Blood Serum Concentration
dose 7, 24 hours
|
9.30 ng/dl
Standard Deviation 4.58
|
|
Testosterone Blood Serum Concentration
dose 7, 36 hours
|
8.20 ng/dl
Standard Deviation 2.71
|
|
Testosterone Blood Serum Concentration
dose 7, 48 hours
|
10.83 ng/dl
Standard Deviation 4.29
|
|
Testosterone Blood Serum Concentration
dose 7, 60 hours
|
10.10 ng/dl
Standard Deviation 4.61
|
|
Testosterone Blood Serum Concentration
Recovery/day 14
|
16.5 ng/dl
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: 7 daysBlood for measurement of serum follicle stimulating hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-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.
Outcome measures
| Measure |
Oral Acyline
n=4 Participants
20 mg dose of GIPET enhanced oral acyline for 7 days
|
|---|---|
|
FSH Blood Serum Concentration
pre-dose 1
|
2.80 iu/L
Standard Deviation 1.55
|
|
FSH Blood Serum Concentration
pre-dose 5
|
2.05 iu/L
Standard Deviation 0.60
|
|
FSH Blood Serum Concentration
pre-dose 6
|
2.33 iu/L
Standard Deviation 0.69
|
|
FSH Blood Serum Concentration
pre-dose 7
|
2.23 iu/L
Standard Deviation 0.72
|
|
FSH Blood Serum Concentration
dose 7, 0.5 hours
|
2.48 iu/L
Standard Deviation 0.67
|
|
FSH Blood Serum Concentration
dose 7, 1 hour
|
2.38 iu/L
Standard Deviation 0.69
|
|
FSH Blood Serum Concentration
dose 7, 1.5 hours
|
2.45 iu/L
Standard Deviation 0.83
|
|
FSH Blood Serum Concentration
dose 7, 2 hours
|
2.45 iu/L
Standard Deviation 0.77
|
|
FSH Blood Serum Concentration
dose 7, 3 hours
|
2.33 iu/L
Standard Deviation 0.78
|
|
FSH Blood Serum Concentration
dose 7, 4 hours
|
2.20 iu/L
Standard Deviation 0.92
|
|
FSH Blood Serum Concentration
dose 7, 6 hours
|
2.05 iu/L
Standard Deviation 0.61
|
|
FSH Blood Serum Concentration
dose 7, 8 hours
|
1.93 iu/L
Standard Deviation 0.62
|
|
FSH Blood Serum Concentration
dose 7, 12 hours
|
2.03 iu/L
Standard Deviation 0.59
|
|
FSH Blood Serum Concentration
dose 7, 24 hours
|
2.28 iu/L
Standard Deviation 0.62
|
|
FSH Blood Serum Concentration
dose 7, 36 hours
|
2.48 iu/L
Standard Deviation 0.85
|
|
FSH Blood Serum Concentration
dose 7, 48 hours
|
3.00 iu/L
Standard Deviation 1.11
|
|
FSH Blood Serum Concentration
dose 7, 60 hours
|
2.93 iu/L
Standard Deviation 1.21
|
|
FSH Blood Serum Concentration
Recovery/day 14
|
3.20 iu/L
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: 7 daysBlood for measurement of serum leutenizing hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-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.
Outcome measures
| Measure |
Oral Acyline
n=4 Participants
20 mg dose of GIPET enhanced oral acyline for 7 days
|
|---|---|
|
LH Blood Serum Concentration
pre-dose 1
|
4.87 iu/L
Standard Deviation 5.53
|
|
LH Blood Serum Concentration
pre-dose 5
|
2.73 iu/L
Standard Deviation 1.53
|
|
LH Blood Serum Concentration
pre-dose 6
|
4.78 iu/L
Standard Deviation 4.43
|
|
LH Blood Serum Concentration
pre-dose 7
|
4.15 iu/L
Standard Deviation 4.60
|
|
LH Blood Serum Concentration
dose 7, 0.5 hours
|
5.80 iu/L
Standard Deviation 2.82
|
|
LH Blood Serum Concentration
dose 7, 1 hour
|
5.18 iu/L
Standard Deviation 3.90
|
|
LH Blood Serum Concentration
dose 7, 1.5 hours
|
5.30 iu/L
Standard Deviation 5.15
|
|
LH Blood Serum Concentration
dose 7, 2 hours
|
5.40 iu/L
Standard Deviation 4.56
|
|
LH Blood Serum Concentration
dose 7, 3 hours
|
3.83 iu/L
Standard Deviation 3.35
|
|
LH Blood Serum Concentration
dose 7, 4 hours
|
2.98 iu/L
Standard Deviation 2.67
|
|
LH Blood Serum Concentration
dose 7, 6 hours
|
2.35 iu/L
Standard Deviation 1.66
|
|
LH Blood Serum Concentration
dose 7, 8 hours
|
1.94 iu/L
Standard Deviation 1.46
|
|
LH Blood Serum Concentration
dose 7, 12 hours
|
2.40 iu/L
Standard Deviation 1.25
|
|
LH Blood Serum Concentration
dose 7, 24 hours
|
4.10 iu/L
Standard Deviation 2.68
|
|
LH Blood Serum Concentration
dose 7, 36 hours
|
6.70 iu/L
Standard Deviation 6.21
|
|
LH Blood Serum Concentration
dose 7, 48 hours
|
7.20 iu/L
Standard Deviation 7.88
|
|
LH Blood Serum Concentration
dose 7, 60 hours
|
5.80 iu/L
Standard Deviation 6.25
|
|
LH Blood Serum Concentration
Recovery/day 14
|
8.10 iu/L
Standard Deviation 9.76
|
Adverse Events
Oral Acyline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place