Trial Outcomes & Findings for Pharmacokinetics of a Single Treatment Cycle of AA4500 0.58 mg in Men With Peyronie's Disease (NCT NCT01430169)
NCT ID: NCT01430169
Last Updated: 2017-10-05
Results Overview
Maximum AUX-I (clostridial type I collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
COMPLETED
PHASE2
20 participants
15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)
2017-10-05
Participant Flow
Participant milestones
| Measure |
AA4500
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg (First Injection is administered on Day 1 and the second Injection is administered on Day 2)
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of a Single Treatment Cycle of AA4500 0.58 mg in Men With Peyronie's Disease
Baseline characteristics by cohort
| Measure |
AA4500
n=20 Participants
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 8.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)Population: Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)
Maximum AUX-I (clostridial type I collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
AA4500
n=17 Participants
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
AUX-I Cmax After Injection 1
|
12.6 ng/mL
Standard Deviation 8.3
|
PRIMARY outcome
Timeframe: 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)Population: Pharmacokinetic (PK) population (N=19).
Maximum AUX-II (clostridium Type II collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
AA4500
n=19 Participants
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
AUX-II Cmax After Injection 1
|
15.1 ng/mL
Standard Deviation 19.2
|
PRIMARY outcome
Timeframe: 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)Population: Pharmacokinetic population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)
Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
AA4500
n=17 Participants
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
AUX-I AUC0-tlast After Injection 1
|
3.1 ng*h/mL
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)Population: Pharmacokinetic (PK) population (N=19)
Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
AA4500
n=19 Participants
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
AUX-II AUC0-tlast After Injection 1
|
2.2 ng*h/mL
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)Population: Pharmacokinetic (PK) population (N=19). For 3 subjects Tmax was considered missing if concentration was BLQ for all time points at that injection and 2 subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)
Time to maximum AUX-I enzyme concentration. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
AA4500
n=14 Participants
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
AUX-I Tmax After Injection 1
|
0.15 hours
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)Population: Pharmacokinetic (PK) population (N=19) One subject was excluded from AUX-II PK analyses due to insufficient quantities of plasma for bioanalysis. Of the 38 AUX-II profiles, 23 had no quantifiable plasma concentrations at any time point through 24 hours post injection.
Time to maximum AUX-II enzyme concentration. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
AA4500
n=8 Participants
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
AUX-II Tmax After Injection 1
|
0.16 hours
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)Population: Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)
Maximum AUX-I enzyme concentration from zero to 24 hours after Injection 2.AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
AA4500
n=17 Participants
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
AUX-I Cmax After Injection 2
|
12.2 ng/mL
Standard Deviation 9.1
|
PRIMARY outcome
Timeframe: 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)Population: Pharmacokinetic (PK) population (N=19)
Maximum AUX-II enzyme concentration from zero to 24 hours after Injection 2. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
AA4500
n=19 Participants
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
AUX-II Cmax After Injection 2
|
16.1 ng/mL
Standard Deviation 23.2
|
PRIMARY outcome
Timeframe: 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)Population: Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)
Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
AA4500
n=17 Participants
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
AUX-I AUC0-tlast After Injection 2
|
2.4 ng*h/mL
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)Population: Pharmacokinetic (PK) population (N=19)
Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
AA4500
n=19 Participants
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
AUX-II AUC0-tlast After Injection 2
|
2.3 ng*h/mL
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)Population: Pharmacokinetic (PK) population (N=19). In addition, 2 subjects have been excluded from the analysis due to ELISA interference. Of the 38 AUX-I profiles, 7 had no quantifiable plasma concentrations through 24 hours post injection.
Time to maximum AUX-I enzyme concentration. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
AA4500
n=13 Participants
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
AUX-I Tmax After Injection 2
|
0.11 hour
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)Population: Pharmacokinetic (PK) population (N=19) In addition, 2 subjects have been excluded from the analysis due to ELISA interference. Of the 38 AUX-II profiles,23 had no quantifiable plasma concentrations at any time point through 24 hours post injection.
Time to maximum AUX-II enzyme concentration. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
AA4500
n=7 Participants
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
AUX-II Tmax After Injection 2
|
0.12 hours
Standard Deviation 0.09
|
Adverse Events
AA4500
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AA4500
n=20 participants at risk
collagenase clostridium histolyticum
AA4500: Two injections of AA4500 0.58 mg
|
|---|---|
|
Reproductive system and breast disorders
Penile haemorrhage
|
95.0%
19/20 • Number of events 23 • 28 days after the first injection
|
|
General disorders
Injection site pain
|
75.0%
15/20 • Number of events 15 • 28 days after the first injection
|
|
Injury, poisoning and procedural complications
Procedural pain
|
45.0%
9/20 • Number of events 10 • 28 days after the first injection
|
|
Reproductive system and breast disorders
Penile swelling
|
30.0%
6/20 • Number of events 6 • 28 days after the first injection
|
|
Reproductive system and breast disorders
Painful erection
|
20.0%
4/20 • Number of events 4 • 28 days after the first injection
|
|
Reproductive system and breast disorders
Penile pain
|
20.0%
4/20 • Number of events 5 • 28 days after the first injection
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
10.0%
2/20 • Number of events 2 • 28 days after the first injection
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Number of events 1 • 28 days after the first injection
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • 28 days after the first injection
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Number of events 1 • 28 days after the first injection
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • 28 days after the first injection
|
|
General disorders
Injection site haemorrhage
|
5.0%
1/20 • Number of events 1 • 28 days after the first injection
|
|
Reproductive system and breast disorders
Penile blister
|
5.0%
1/20 • Number of events 1 • 28 days after the first injection
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
5.0%
1/20 • Number of events 1 • 28 days after the first injection
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER