Trial Outcomes & Findings for Phase II Pharmacokinetics Study of CAM2038 (NCT NCT02710526)
NCT ID: NCT02710526
Last Updated: 2020-04-30
Results Overview
Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.
Results posted on
2020-04-30
Participant Flow
Participant milestones
| Measure |
32 mg CAM2038 Weekly
Group 1, 32 mg of CAM2038 subcutaneous weekly injections at multiple injection sites
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
128 mg CAM2038 Monthly Injection
Group 2: 128 mg of CAM2038 subcutaneous monthly injections during Treatment Phase and 32 mg of CAM2038 subcutaneous weekly injections during Safety Extension in the buttocks
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
160 mg CAM2038 Monthly Injection
Group 3: 24 mg SL BPN for the first 7 days and then 160 mg of CAM2038 subcutaneous monthly injections in the buttocks starting on Day 8
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|
|
Treatment Phase
STARTED
|
28
|
20
|
18
|
|
Treatment Phase
COMPLETED
|
22
|
16
|
12
|
|
Treatment Phase
NOT COMPLETED
|
6
|
4
|
6
|
|
Safety Extension
STARTED
|
15
|
12
|
0
|
|
Safety Extension
COMPLETED
|
14
|
12
|
0
|
|
Safety Extension
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Pharmacokinetics Study of CAM2038
Baseline characteristics by cohort
| Measure |
32 mg CAM2038 Weekly
n=28 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at multiple injection sites
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
128 mg CAM2038 Monthly Injection
n=20 Participants
Group 2: 128 mg of CAM2038 subcutaneous monthly injection in the buttocks
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
160 mg CAM2038 Monthly Injection
n=17 Participants
Group 3: 24 mg SL BPN for the first 7 days and then 160 mg of CAM2038 subcutaneous monthly injection in the buttocks starting on Day 8
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 10.83 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 11.49 • n=7 Participants
|
44.1 years
STANDARD_DEVIATION 12.23 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 11.37 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
BMI
|
26.0 kg/m^2
STANDARD_DEVIATION 3.95 • n=5 Participants
|
27.0 kg/m^2
STANDARD_DEVIATION 4.25 • n=7 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 3.72 • n=5 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 4.04 • n=4 Participants
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest.
AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
n=20 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population
|
700 ng*h/mL
Geometric Coefficient of Variation 27.1
|
657 ng*h/mL
Geometric Coefficient of Variation 27.2
|
613 ng*h/mL
Geometric Coefficient of Variation 36.8
|
591 ng*h/mL
Geometric Coefficient of Variation 33.7
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
n=20 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population
|
4.17 ng/mL
Geometric Coefficient of Variation 27.1
|
3.91 ng/mL
Geometric Coefficient of Variation 27.2
|
3.65 ng/mL
Geometric Coefficient of Variation 36.8
|
3.52 ng/mL
Geometric Coefficient of Variation 33.7
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site.
|
6.87 ng/mL
Geometric Coefficient of Variation 37.2
|
6.56 ng/mL
Geometric Coefficient of Variation 29.9
|
5.37 ng/mL
Geometric Coefficient of Variation 43.6
|
5.69 ng/mL
Geometric Coefficient of Variation 43.1
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
Tss,max (time to maximum concentration at steady state) for each injection site-buprenorphine
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site
|
24.0 h
Interval 0.0 to 72.0
|
24.0 h
Interval 0.0 to 168.0
|
24.0 h
Interval 10.0 to 120.0
|
24.0 h
Interval 4.0 to 48.0
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Buprenorphine for Pharmacokinetic Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=16 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=12 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Buprenorphine
|
2610 ng*h/mL
Geometric Coefficient of Variation 41.7
|
3540 ng*h/mL
Geometric Coefficient of Variation 26.1
|
—
|
—
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
Average steady state concentration-Buprenorphine-Pharmacokinetic Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=16 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=11 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Average Steady State Concentration-Buprenorphine
|
3.89 ng/mL
Geometric Coefficient of Variation 41.7
|
5.27 ng/mL
Geometric Coefficient of Variation 26.1
|
—
|
—
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
Maximum steady state concentration-BuprenorphinePharmacokinetic (PK) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=16 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=12 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=16 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Maximum Steady State Concentration-Buprenorphine
|
11.1 ng/mL
Geometric Coefficient of Variation 54.1
|
15.4 ng/mL
Geometric Coefficient of Variation 52.0
|
11.1 ng/mL
Geometric Coefficient of Variation 61.4
|
—
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
Time to maximum concentration at steady state-Buprenorphine Pharmacokinetic (PK) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=16 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=12 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=16 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Time to Maximum Concentration at Steady State-Buprenorphine
|
10.0 h
Interval 1.0 to 48.0
|
24.0 h
Interval 6.1 to 48.3
|
1.69 h
Interval 0.0 to 4.07
|
—
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
Norbuprenorphine/buprenorphine ratios at maximum concentration at steady state Evaluable Pharmacokinetic (PKEVAL) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State
|
0.305 ratio
Geometric Coefficient of Variation 59.1
|
0.307 ratio
Geometric Coefficient of Variation 53.9
|
0.366 ratio
Geometric Coefficient of Variation 60.3
|
0.366 ratio
Geometric Coefficient of Variation 55.2
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Norbuprenorphine Evaluable Pharmacokinetic (PKEVAL) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=18 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=17 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=17 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
n=17 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm.
|
204 ng*h/mL
Geometric Coefficient of Variation 70.5
|
192 ng*h/mL
Geometric Coefficient of Variation 69.0
|
208 ng*h/mL
Geometric Coefficient of Variation 90.9
|
197 ng*h/mL
Geometric Coefficient of Variation 70.1
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=18 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=17 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=17 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
n=17 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site
|
1.22 ng/mL
Geometric Coefficient of Variation 64.3
|
1.15 ng/mL
Geometric Coefficient of Variation 69.0
|
1.24 ng/mL
Geometric Coefficient of Variation 90.9
|
1.17 ng/mL
Geometric Coefficient of Variation 70.1
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site.
|
1.85 ng/mL
Geometric Coefficient of Variation 74.5
|
1.78 ng/mL
Geometric Coefficient of Variation 67.2
|
1.74 ng/mL
Geometric Coefficient of Variation 86.7
|
1.84 ng/mL
Geometric Coefficient of Variation 78.2
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
Tss,max (time to maximum concentration at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site
|
72.0 h
Interval 0.0 to 120.0
|
72.0 h
Interval 0.0 to 168.0
|
72.0 h
Interval 0.5 to 168.0
|
30.0 h
Interval 0.0 to 168.0
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.Population: Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest
Norbuprenorphine/buprenorphine ratios for Area Under the Curve at steady state Evaluable Pharmacokinetic (PKEVAL) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=21 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
n=20 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Norbuprenorphine/Buprenorphine Ratios for Area Under the Curve at Steady State
|
0.354 ratio
Geometric Coefficient of Variation 57.4
|
0.341 ratio
Geometric Coefficient of Variation 52.5
|
0.355 ratio
Geometric Coefficient of Variation 54.4
|
0.370 ratio
Geometric Coefficient of Variation 50.7
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Norepinephrine-Pharmacokinetic (PK) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=16 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=11 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Norepinephrine
|
795 ng*h/mL
Geometric Coefficient of Variation 130.5
|
1590 ng*h/mL
Geometric Coefficient of Variation 55.1
|
—
|
—
|
PRIMARY outcome
Timeframe: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
Average steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=16 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=11 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Average Steady State Concentration-Norbuprenorphine
|
1.18 ng/mL
Geometric Coefficient of Variation 130.5
|
2.37 ng/mL
Geometric Coefficient of Variation 55.1
|
—
|
—
|
PRIMARY outcome
Timeframe: PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
Maximum steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=16 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=12 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=16 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Maximum Steady State Concentration-Norbuprenorphine
|
2.14 ng/mL
Geometric Coefficient of Variation 122.8
|
4.61 ng/mL
Geometric Coefficient of Variation 54.5
|
7.92 ng/mL
Geometric Coefficient of Variation 75.6
|
—
|
PRIMARY outcome
Timeframe: PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7Population: Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.
Time to maximum concentration at steady state-Norbuprenorphine-Pharmacokinetic (PK) Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=16 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=12 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=16 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Time to Maximum Concentration at Steady State-Norbuprenorphine
|
84.1 h
Interval 0.5 to 244.0
|
121 h
Interval 2.17 to 671.0
|
1.78 h
Interval 0.68 to 6.47
|
—
|
SECONDARY outcome
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3Population: Safety Population: included all subjects who received CAM2038
Number of Participants with Adverse Events for Both weekly and monthly CAM2038-Safety Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=28 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=20 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=17 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with TEAEs
|
14 participants
|
10 participants
|
9 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with Serious TEAEs
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with suspected to be drug-related TEAEs
|
4 participants
|
3 participants
|
2 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with AEs that resulted in death
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with at least 1 AE
|
14 participants
|
10 participants
|
9 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with mild grade AEs
|
3 participants
|
4 participants
|
4 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with moderate grade AEs
|
11 participants
|
5 participants
|
5 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with severe grade AEs
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with at least 1 injection site TEAE
|
3 participants
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with mild grade injection site AEs
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with moderate grade injection site AEs
|
3 participants
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with severe grade injection site AEs
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with at least 1 non-injection site AE
|
13 participants
|
10 participants
|
9 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subject with mild grade non-injection site AEs
|
3 participants
|
4 participants
|
4 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subject with moderate grade non-injection site AEs
|
10 participants
|
5 participants
|
5 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with severe grade non-injection site AEs
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038
Subjects with TEAEs that led to drug withdrawn
|
0 participants
|
0 participants
|
0 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3Population: ITT Population-consisted of all subjects who received at least 1 injection of CAM2038 and provided some efficacy measures. Participants did not always enter pain scores in electronic diaries. Also, participants early terminated during the study and stopped entering scores.
Summary of Average Daily Pain, using an 11-point Numerical Rating Scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable. (ITT Population)
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=28 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=20 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=17 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Summary of Average Daily Pain by Week (ITT Population)
Baseline
|
5.7 score on a scale
Standard Deviation 1.06
|
6.7 score on a scale
Standard Deviation 2.28
|
5.0 score on a scale
Standard Deviation 2.18
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 1
|
4.4 score on a scale
Standard Deviation 2.37
|
3.4 score on a scale
Standard Deviation 2.25
|
4.5 score on a scale
Standard Deviation 2.12
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 2
|
4.0 score on a scale
Standard Deviation 2.19
|
3.7 score on a scale
Standard Deviation 2.44
|
4.1 score on a scale
Standard Deviation 1.52
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 3
|
3.9 score on a scale
Standard Deviation 2.18
|
4.0 score on a scale
Standard Deviation 2.59
|
4.5 score on a scale
Standard Deviation 1.79
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 4
|
3.2 score on a scale
Standard Deviation 2.08
|
3.9 score on a scale
Standard Deviation 2.71
|
4.4 score on a scale
Standard Deviation 2.10
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 5
|
3.3 score on a scale
Standard Deviation 2.00
|
3.0 score on a scale
Standard Deviation 1.99
|
4.0 score on a scale
Standard Deviation 1.84
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 6
|
3.2 score on a scale
Standard Deviation 1.88
|
3.2 score on a scale
Standard Deviation 2.39
|
3.7 score on a scale
Standard Deviation 1.76
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 7
|
3.0 score on a scale
Standard Deviation 2.01
|
3.7 score on a scale
Standard Deviation 2.20
|
4.3 score on a scale
Standard Deviation 1.88
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 8
|
3.5 score on a scale
Standard Deviation 1.47
|
3.9 score on a scale
Standard Deviation 2.00
|
4.8 score on a scale
Standard Deviation 2.04
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 9
|
3.7 score on a scale
Standard Deviation 1.88
|
3.5 score on a scale
Standard Deviation 2.27
|
3.7 score on a scale
Standard Deviation 2.05
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 10
|
3.3 score on a scale
Standard Deviation 1.50
|
3.3 score on a scale
Standard Deviation 1.94
|
4.1 score on a scale
Standard Deviation 2.11
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 11
|
3.9 score on a scale
Standard Deviation 1.66
|
3.0 score on a scale
Standard Deviation 2.10
|
4.1 score on a scale
Standard Deviation 2.23
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 12
|
3.6 score on a scale
Standard Deviation 1.51
|
3.6 score on a scale
Standard Deviation 1.98
|
4.4 score on a scale
Standard Deviation 2.23
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 13
|
3.9 score on a scale
Standard Deviation 1.63
|
2.8 score on a scale
Standard Deviation 2.23
|
3.1 score on a scale
Standard Deviation 1.81
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 14
|
6.0 score on a scale
Standard Deviation 3.42
|
3.2 score on a scale
Standard Deviation 1.98
|
3.8 score on a scale
Standard Deviation 1.80
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 15
|
—
|
3.2 score on a scale
Standard Deviation 2.16
|
4.1 score on a scale
Standard Deviation 1.91
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 16
|
—
|
3.9 score on a scale
Standard Deviation 2.30
|
4.5 score on a scale
Standard Deviation 2.15
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 17
|
—
|
4.1 score on a scale
Standard Deviation 1.92
|
4.3 score on a scale
Standard Deviation 1.44
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 18
|
—
|
3.9 score on a scale
Standard Deviation 2.46
|
—
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 19
|
—
|
4.2 score on a scale
Standard Deviation 2.22
|
—
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 20
|
—
|
4.4 score on a scale
Standard Deviation 1.93
|
—
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 21
|
—
|
4.3 score on a scale
Standard Deviation 2.06
|
—
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 22
|
—
|
4.2 score on a scale
Standard Deviation 2.40
|
—
|
—
|
|
Summary of Average Daily Pain by Week (ITT Population)
Week 23
|
—
|
6.0 score on a scale
Standard Deviation NA
Only one participant entered a score, so no SD.
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3Population: ITT Population: included all subjects who received at least one dose of CAM2038 and provided some efficacy measures-Note that some patients dropped from the study so the numbers at the baseline may be different from later visits.
Number of Participants with confirmed Opiate Independence as confirmed by Negative Urine Toxicology Tests-ITT Population
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=28 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=20 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=17 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 92
|
6 Participants
|
9 Participants
|
9 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Baseline
|
16 Participants
|
12 Participants
|
14 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 1
|
13 Participants
|
11 Participants
|
13 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 2
|
14 Participants
|
12 Participants
|
15 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 3
|
—
|
—
|
15 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 4
|
—
|
—
|
13 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 5
|
—
|
—
|
13 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 6
|
—
|
—
|
15 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 7
|
—
|
—
|
15 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 8
|
13 Participants
|
12 Participants
|
11 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 9
|
—
|
—
|
14 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 15
|
11 Participants
|
10 Participants
|
12 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 22
|
12 Participants
|
9 Participants
|
9 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 23
|
14 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 24
|
14 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 25
|
13 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 26
|
13 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 27
|
15 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 29
|
12 Participants
|
9 Participants
|
10 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 30
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 31
|
11 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 32
|
12 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 33
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 34
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 36
|
11 Participants
|
9 Participants
|
13 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 37
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 38
|
11 Participants
|
—
|
11 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 39
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 40
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 41
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 43
|
10 Participants
|
10 Participants
|
14 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 44
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 45
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 46
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 47
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 48
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 50
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 57
|
—
|
10 Participants
|
13 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 59
|
—
|
9 Participants
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 64
|
—
|
10 Participants
|
12 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 66
|
—
|
—
|
12 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 71
|
7 Participants
|
9 Participants
|
10 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 78
|
—
|
9 Participants
|
12 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 85
|
—
|
10 Participants
|
13 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 86
|
—
|
9 Participants
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 87
|
—
|
9 Participants
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 88
|
—
|
9 Participants
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 89
|
—
|
9 Participants
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 90
|
—
|
8 Participants
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 93
|
—
|
—
|
9 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 94
|
—
|
—
|
9 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 95
|
—
|
8 Participants
|
9 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 96
|
—
|
—
|
9 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 97
|
—
|
—
|
10 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 99
|
—
|
10 Participants
|
9 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 102
|
—
|
—
|
7 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 106
|
—
|
8 Participants
|
9 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 113
|
—
|
11 Participants
|
8 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 120
|
—
|
—
|
12 Participants
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 134
|
—
|
5 Participants
|
—
|
—
|
|
Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests
Day 155
|
—
|
7 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3Population: Safety Population: included all subjects who received CAM2038. Participants did not always enter pain scores in electronic diaries. Also, participants early terminated during the study and stopped entering scores.
Subject-rated worst daily pain, using an 11-point numerical rating scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects-Safety Population. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable.
Outcome measures
| Measure |
32 mg CAM2038 Weekly-Buttock
n=28 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Buttock
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Abdomen
n=20 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Abdomen
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Thigh
n=17 Participants
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Thigh
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
32 mg CAM2038 Weekly-Upper Arm
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at Upper Arm
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
|---|---|---|---|---|
|
Subject-rated Worst Daily Pain
Week 18
|
—
|
5.7 score on a scale
Standard Deviation 2.13
|
—
|
—
|
|
Subject-rated Worst Daily Pain
Week 19
|
—
|
5.8 score on a scale
Standard Deviation 2.03
|
—
|
—
|
|
Subject-rated Worst Daily Pain
Week 3
|
5.3 score on a scale
Standard Deviation 2.25
|
5.3 score on a scale
Standard Deviation 2.77
|
5.4 score on a scale
Standard Deviation 2.05
|
—
|
|
Subject-rated Worst Daily Pain
Baseline
|
7.6 score on a scale
Standard Deviation 0.33
|
8.3 score on a scale
Standard Deviation 1.30
|
6.1 score on a scale
Standard Deviation 2.07
|
—
|
|
Subject-rated Worst Daily Pain
Week 1
|
5.8 score on a scale
Standard Deviation 2.40
|
4.9 score on a scale
Standard Deviation 2.79
|
5.6 score on a scale
Standard Deviation 2.10
|
—
|
|
Subject-rated Worst Daily Pain
Week 2
|
5.4 score on a scale
Standard Deviation 2.27
|
5.2 score on a scale
Standard Deviation 2.49
|
5.4 score on a scale
Standard Deviation 1.85
|
—
|
|
Subject-rated Worst Daily Pain
Week 4
|
4.6 score on a scale
Standard Deviation 2.23
|
5.5 score on a scale
Standard Deviation 2.92
|
5.6 score on a scale
Standard Deviation 2.31
|
—
|
|
Subject-rated Worst Daily Pain
Week 5
|
4.8 score on a scale
Standard Deviation 2.28
|
4.2 score on a scale
Standard Deviation 2.08
|
5.3 score on a scale
Standard Deviation 1.88
|
—
|
|
Subject-rated Worst Daily Pain
Week 6
|
4.7 score on a scale
Standard Deviation 2.04
|
4.6 score on a scale
Standard Deviation 2.70
|
5.2 score on a scale
Standard Deviation 1.98
|
—
|
|
Subject-rated Worst Daily Pain
Week 7
|
4.3 score on a scale
Standard Deviation 2.11
|
4.9 score on a scale
Standard Deviation 2.44
|
5.8 score on a scale
Standard Deviation 2.32
|
—
|
|
Subject-rated Worst Daily Pain
Week 8
|
5.2 score on a scale
Standard Deviation 1.53
|
5.5 score on a scale
Standard Deviation 2.52
|
6.1 score on a scale
Standard Deviation 2.08
|
—
|
|
Subject-rated Worst Daily Pain
Week 9
|
5.3 score on a scale
Standard Deviation 1.55
|
5.2 score on a scale
Standard Deviation 2.73
|
4.9 score on a scale
Standard Deviation 2.19
|
—
|
|
Subject-rated Worst Daily Pain
Week 10
|
4.9 score on a scale
Standard Deviation 1.69
|
4.8 score on a scale
Standard Deviation 2.60
|
5.2 score on a scale
Standard Deviation 2.02
|
—
|
|
Subject-rated Worst Daily Pain
Week 11
|
5.2 score on a scale
Standard Deviation 1.39
|
4.5 score on a scale
Standard Deviation 2.62
|
5.3 score on a scale
Standard Deviation 2.32
|
—
|
|
Subject-rated Worst Daily Pain
Week 12
|
5.2 score on a scale
Standard Deviation 1.53
|
5.2 score on a scale
Standard Deviation 2.30
|
5.9 score on a scale
Standard Deviation 2.34
|
—
|
|
Subject-rated Worst Daily Pain
Week 13
|
5.1 score on a scale
Standard Deviation 1.58
|
4.4 score on a scale
Standard Deviation 2.70
|
4.4 score on a scale
Standard Deviation 2.14
|
—
|
|
Subject-rated Worst Daily Pain
Week 14
|
6.4 score on a scale
Standard Deviation 3.76
|
4.6 score on a scale
Standard Deviation 2.37
|
5.1 score on a scale
Standard Deviation 1.96
|
—
|
|
Subject-rated Worst Daily Pain
Week 15
|
—
|
4.5 score on a scale
Standard Deviation 2.54
|
5.5 score on a scale
Standard Deviation 2.08
|
—
|
|
Subject-rated Worst Daily Pain
Week 16
|
—
|
5.5 score on a scale
Standard Deviation 2.37
|
5.8 score on a scale
Standard Deviation 2.24
|
—
|
|
Subject-rated Worst Daily Pain
Week 17
|
—
|
5.9 score on a scale
Standard Deviation 1.76
|
4.3 score on a scale
Standard Deviation 0.76
|
—
|
|
Subject-rated Worst Daily Pain
Week 20
|
—
|
6.3 score on a scale
Standard Deviation 1.16
|
—
|
—
|
|
Subject-rated Worst Daily Pain
Week 21
|
—
|
6.1 score on a scale
Standard Deviation 1.61
|
—
|
—
|
|
Subject-rated Worst Daily Pain
Week 22
|
—
|
5.8 score on a scale
Standard Deviation 1.98
|
—
|
—
|
|
Subject-rated Worst Daily Pain
Week 23
|
—
|
8.0 score on a scale
Standard Deviation NA
Only one participant entered a pain score, so no SD.
|
—
|
—
|
Adverse Events
32 mg CAM2038 Weekly
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
128 mg CAM2038 Monthly Injection
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
160 mg CAM2038 Monthly Injection
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
24 mg SL BPN
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
32 mg CAM2038 Weekly
n=28 participants at risk
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at multiple injection sites
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
128 mg CAM2038 Monthly Injection
n=20 participants at risk
Group 2: 128 mg of CAM2038 subcutaneous monthly injection in the buttocks
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
160 mg CAM2038 Monthly Injection
n=17 participants at risk
Group 3: 160 mg of CAM2038 subcutaneous monthly injection in the buttocks
CAM2038: Long-Acting Subcutaneous Injectable Depot of Buprenorphine
|
24 mg SL BPN
n=18 participants at risk
Group 3: 24 mg Sublingual Buprenorphine (SL BPN) from day 1-7 in group 3
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/28 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/28 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28 • Number of events 1 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
1/28 • Number of events 1 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Gastrointestinal disorders
Nausea
|
7.1%
2/28 • Number of events 2 • 2 years 3 months
|
10.0%
2/20 • Number of events 2 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Gastrointestinal disorders
Toothache
|
7.1%
2/28 • Number of events 2 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
General disorders
Fatigue
|
0.00%
0/28 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
General disorders
Injection site erythema
|
7.1%
2/28 • Number of events 2 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
General disorders
Injection Site Swelling
|
10.7%
3/28 • Number of events 3 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/28 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Infections and infestations
Herpes Zester
|
0.00%
0/28 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Infections and infestations
Influenza
|
0.00%
0/28 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/28 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/28 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Infections and infestations
Tooth Abscess
|
3.6%
1/28 • Number of events 1 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.6%
1/28 • Number of events 1 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Infections and infestations
Urinary Tract Infection
|
7.1%
2/28 • Number of events 2 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
11.8%
2/17 • Number of events 2 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/28 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/28 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Investigations
Asparatate aminotransferase inceased
|
0.00%
0/28 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Investigations
Blood creatine phosphokinase increased
|
3.6%
1/28 • Number of events 1 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/28 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/28 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/28 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Nervous system disorders
Dizzyness
|
0.00%
0/28 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Nervous system disorders
Headache
|
0.00%
0/28 • 2 years 3 months
|
10.0%
2/20 • Number of events 2 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/28 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Nervous system disorders
Anxiety
|
0.00%
0/28 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
11.8%
2/17 • Number of events 2 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/28 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/28 • 2 years 3 months
|
0.00%
0/20 • 2 years 3 months
|
5.9%
1/17 • Number of events 1 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/28 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/28 • 2 years 3 months
|
5.0%
1/20 • Number of events 1 • 2 years 3 months
|
0.00%
0/17 • 2 years 3 months
|
0.00%
0/18 • 2 years 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60