Trial Outcomes & Findings for Congenital Muscular Dystrophy Ascending Multiple Dose Cohort Study Analyzing Pharmacokinetics at Three Dose Levels In Children and Adolescents With Assessment of Safety and Tolerability of Omigapil (CALLISTO) (NCT NCT01805024)
NCT ID: NCT01805024
Last Updated: 2021-09-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
0.5, 1, 1.5, 2, 4 and 8 hours post-dose on Day 1, Week 4 and Week 12
Results posted on
2021-09-24
Participant Flow
Participant milestones
| Measure |
Cohort 1 0.02 mg/kg/Day
Omigapil Treatment, oral administration once per day after breakfast
|
Cohort 2 0.08 mg/kg/Day
Omigapil Treatment, oral administration once per day after breakfast
|
Cohort 3a 0.04 mg/kg/Day
Omigapil Treatment, oral administration once per day after breakfast
|
Cohort 3b 0.06 mg/kg/Day
Omigapil Treatment, oral administration once per day after breakfast
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
8
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Congenital Muscular Dystrophy Ascending Multiple Dose Cohort Study Analyzing Pharmacokinetics at Three Dose Levels In Children and Adolescents With Assessment of Safety and Tolerability of Omigapil (CALLISTO)
Baseline characteristics by cohort
| Measure |
Cohort 1 0.02 mg/kg/Day
n=4 Participants
Omigapil treatment, oral administration once per day after breakfast
|
Cohort 2 0.08 mg/kg/Day
n=4 Participants
Omigapil treatment, oral administration once per day after breakfast
|
Cohort 3a 0.04 mg/kg/Day
n=4 Participants
Omigapil treatment, oral administration once per day after breakfast
|
Cohort 3b 0.06 mg/kg/Day
n=8 Participants
Omigapil treatment, oral administration once per day after breakfast
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.9 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
10.2 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
9.3 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
11.2 years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
10.2 years
STANDARD_DEVIATION 3.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Aisan
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 4 and 8 hours post-dose on Day 1, Week 4 and Week 12Outcome measures
| Measure |
Cohort 1 0.02 mg/kg/Day
n=4 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
Cohort 2 0.08 mg/kg/Day
n=4 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
Cohort 3a 0.04 mg/kg/Day
n=4 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
Cohort 3b 0.06 mg/kg/Day
n=8 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
|---|---|---|---|---|
|
Pharmacokinetic Profile of Omigapil:Maximum Observed Plasma Concentration (Cmax) of Omigapil
Week 12
|
1.25 ng/mL
Geometric Coefficient of Variation 37.8
|
11.6 ng/mL
Geometric Coefficient of Variation 51.6
|
1.95 ng/mL
Geometric Coefficient of Variation 31.9
|
3.43 ng/mL
Geometric Coefficient of Variation 55.2
|
|
Pharmacokinetic Profile of Omigapil:Maximum Observed Plasma Concentration (Cmax) of Omigapil
Day1
|
1.05 ng/mL
Geometric Coefficient of Variation 32.4
|
4.75 ng/mL
Geometric Coefficient of Variation 24.9
|
2.15 ng/mL
Geometric Coefficient of Variation 62.8
|
3.27 ng/mL
Geometric Coefficient of Variation 86.4
|
|
Pharmacokinetic Profile of Omigapil:Maximum Observed Plasma Concentration (Cmax) of Omigapil
Week 4
|
1.10 ng/mL
Geometric Coefficient of Variation 55.1
|
10.5 ng/mL
Geometric Coefficient of Variation 57.3
|
1.98 ng/mL
Geometric Coefficient of Variation 31.2
|
2.90 ng/mL
Geometric Coefficient of Variation 96.1
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 4 and 8 hours post-dose on Day 1, Week 4 and Week 12Outcome measures
| Measure |
Cohort 1 0.02 mg/kg/Day
n=4 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
Cohort 2 0.08 mg/kg/Day
n=4 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
Cohort 3a 0.04 mg/kg/Day
n=4 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
Cohort 3b 0.06 mg/kg/Day
n=8 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
|---|---|---|---|---|
|
Pharmacokinetic Profile of Omigapil: Time at Which Cmax Was Apparent (Tmax) of Omigapil
Day 1
|
0.8 h
Geometric Coefficient of Variation 3.9
|
0.8 h
Geometric Coefficient of Variation 1.5
|
0.8 h
Geometric Coefficient of Variation 3.9
|
0.5 h
Geometric Coefficient of Variation 4.0
|
|
Pharmacokinetic Profile of Omigapil: Time at Which Cmax Was Apparent (Tmax) of Omigapil
Week 4
|
0.6 h
Geometric Coefficient of Variation 1.5
|
0.5 h
Geometric Coefficient of Variation 2.0
|
0.5 h
Geometric Coefficient of Variation 1.0
|
1.0 h
Geometric Coefficient of Variation 4.0
|
|
Pharmacokinetic Profile of Omigapil: Time at Which Cmax Was Apparent (Tmax) of Omigapil
Week 12
|
1.00 h
Geometric Coefficient of Variation 1.6
|
0.9 h
Geometric Coefficient of Variation 1.4
|
0.8 h
Geometric Coefficient of Variation 1.0
|
1.0 h
Geometric Coefficient of Variation 4.0
|
PRIMARY outcome
Timeframe: 0 to 8 hours post-dose on Day 1, Week 4, Week 12Outcome measures
| Measure |
Cohort 1 0.02 mg/kg/Day
n=4 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
Cohort 2 0.08 mg/kg/Day
n=4 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
Cohort 3a 0.04 mg/kg/Day
n=4 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
Cohort 3b 0.06 mg/kg/Day
n=8 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
|---|---|---|---|---|
|
Pharmacokinetic Profile of Omigapil Area Under the Plasma Concentration Versus Time Curve From Time Zero to 8h Post-dose (AUC0-8)
Week 4
|
3.47 mg.h/ml
Geometric Coefficient of Variation 48.2
|
29.7 mg.h/ml
Geometric Coefficient of Variation 64.1
|
8.28 mg.h/ml
Geometric Coefficient of Variation 15.7
|
11.0 mg.h/ml
Geometric Coefficient of Variation 77.8
|
|
Pharmacokinetic Profile of Omigapil Area Under the Plasma Concentration Versus Time Curve From Time Zero to 8h Post-dose (AUC0-8)
Day 1
|
3.37 mg.h/ml
Geometric Coefficient of Variation 23.0
|
15.7 mg.h/ml
Geometric Coefficient of Variation 38.5
|
7.12 mg.h/ml
Geometric Coefficient of Variation 34.4
|
10.8 mg.h/ml
Geometric Coefficient of Variation 69.5
|
|
Pharmacokinetic Profile of Omigapil Area Under the Plasma Concentration Versus Time Curve From Time Zero to 8h Post-dose (AUC0-8)
Week 12
|
3.79 mg.h/ml
Geometric Coefficient of Variation 47.9
|
37.5 mg.h/ml
Geometric Coefficient of Variation 31.0
|
6.91 mg.h/ml
Geometric Coefficient of Variation 18.5
|
12.5 mg.h/ml
Geometric Coefficient of Variation 91.6
|
SECONDARY outcome
Timeframe: 12 weeksTEAEs reported during the treatment period
Outcome measures
| Measure |
Cohort 1 0.02 mg/kg/Day
n=4 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
Cohort 2 0.08 mg/kg/Day
n=4 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
Cohort 3a 0.04 mg/kg/Day
n=4 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
Cohort 3b 0.06 mg/kg/Day
n=8 Participants
Omigapil Treatment Oral Administration once per day after breakfast
|
|---|---|---|---|---|
|
Summary of All Treatment-emergent Adverse Events (TEAEs)
Treatment-emergent TEAEs
|
41 number of events
|
40 number of events
|
29 number of events
|
75 number of events
|
|
Summary of All Treatment-emergent Adverse Events (TEAEs)
Serious TEAEs
|
0 number of events
|
0 number of events
|
0 number of events
|
0 number of events
|
|
Summary of All Treatment-emergent Adverse Events (TEAEs)
Fatal TEAEs
|
0 number of events
|
0 number of events
|
0 number of events
|
0 number of events
|
Adverse Events
Cohort 1 0.02 mg/kg/Day
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2 0.08 mg/kg/Day
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3a 0.04 mg/kg/Day
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3b 0.06 mg/kg/Day
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 0.02 mg/kg/Day
n=4 participants at risk
Omigapil Treatment, oral Administration once per day after breakfast
|
Cohort 2 0.08 mg/kg/Day
n=4 participants at risk
Omigapil Treatment, oral Administration once per day after breakfast
|
Cohort 3a 0.04 mg/kg/Day
n=4 participants at risk
Omigapil Treatment, oral Administration once per day after breakfast
|
Cohort 3b 0.06 mg/kg/Day
n=8 participants at risk
Omigapil Treatment, oral Administration once per day after breakfast
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Eye disorders
Ocular hyperaemia
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
50.0%
2/4 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
2/8 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Gastrointestinal disorders
Faeces discoloured
|
25.0%
1/4 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
2/8 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 3 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
General disorders
Chest pain
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
General disorders
Fatigue
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
General disorders
Injection site pain
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
General disorders
Pyrexia
|
50.0%
2/4 • Number of events 3 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Infections and infestations
Stoma site cellulitis
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
37.5%
3/8 • Number of events 3 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
50.0%
4/8 • Number of events 5 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Investigations
Blood cholesterol increased
|
50.0%
2/4 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 3 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Investigations
Granulocyte count increased
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Investigations
Protein total decreased
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Investigations
Pulmonary function test decreased
|
50.0%
2/4 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
75.0%
3/4 • Number of events 3 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
50.0%
4/8 • Number of events 5 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Investigations
Red blood cells urine
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Investigations
Ultrasound liver abnormal
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Investigations
White blood cells urine positive
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
37.5%
3/8 • Number of events 4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
75.0%
3/4 • Number of events 3 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
37.5%
3/8 • Number of events 12 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Psychiatric disorders
Anorexia and bulimia syndrome
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Psychiatric disorders
Attention déficit / hyperactivity disorder
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Psychiatric disorders
Irritability
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
2/8 • Number of events 3 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
50.0%
2/4 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 3 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
50.0%
2/4 • Number of events 3 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
75.0%
3/4 • Number of events 8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
2/8 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
50.0%
4/8 • Number of events 4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
100.0%
4/4 • Number of events 6 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 3 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
100.0%
4/4 • Number of events 9 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
2/8 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Skin and subcutaneous tissue disorders
Blister
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Vascular disorders
Flushing
|
25.0%
1/4 • Number of events 2 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/8 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
0.00%
0/4 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
25.0%
1/4 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
12.5%
1/8 • Number of events 1 • Treatment-emergent AEs (TEAEs) collected during the 12 weeks of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Cooperative Research and Development Agreement
- Publication restrictions are in place
Restriction type: OTHER