Trial Outcomes & Findings for A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C (NCT NCT00630058)
NCT ID: NCT00630058
Last Updated: 2026-01-06
Results Overview
Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Data were collected at Day1 to Day85
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
Group A (MP-424 High)
Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
Group B (MP-424 Low)
Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Group A (MP-424 High)
Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
Group B (MP-424 Low)
Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
stopping criteria
|
3
|
2
|
Baseline Characteristics
A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C
Baseline characteristics by cohort
| Measure |
Group A (MP-424 High)
n=10 Participants
Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
Group B (MP-424 Low)
n=10 Participants
Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 6.8 • n=37 Participants
|
54.3 years
STANDARD_DEVIATION 8.5 • n=56 Participants
|
52.2 years
STANDARD_DEVIATION 7.8 • n=82 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=37 Participants
|
6 Participants
n=56 Participants
|
10 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=37 Participants
|
4 Participants
n=56 Participants
|
10 Participants
n=82 Participants
|
PRIMARY outcome
Timeframe: Data were collected at Day1 to Day85Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Outcome measures
| Measure |
Group B (MP-424 Low)
n=10 Participants
Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
Group A (MP-424 High)
n=10 Participants
Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
|---|---|---|
|
Cmax (Maximum Observed Concentration in Plasma) of MP-424
Day 14 (Group A,B:10 cases)
|
3.06 μg/mL
Standard Deviation 0.90
|
3.96 μg/mL
Standard Deviation 1.10
|
|
Cmax (Maximum Observed Concentration in Plasma) of MP-424
Day 85 (Group A: 6 cases, Group B: 7 cases)
|
3.16 μg/mL
Standard Deviation 1.10
|
3.67 μg/mL
Standard Deviation 0.87
|
|
Cmax (Maximum Observed Concentration in Plasma) of MP-424
Day 1 (Group A,B:10 cases)
|
1.45 μg/mL
Standard Deviation 0.83
|
1.62 μg/mL
Standard Deviation 0.43
|
PRIMARY outcome
Timeframe: Data were collected at Day1 to Day85Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Outcome measures
| Measure |
Group B (MP-424 Low)
n=10 Participants
Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
Group A (MP-424 High)
n=10 Participants
Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
|---|---|---|
|
Tmax (Time of Maximum Concentration in Plasma) of MP-424
Day 1 (Group A, B:10 cases)
|
2.54 hours
Interval 2.33 to 8.02
|
2.51 hours
Interval 2.25 to 6.0
|
|
Tmax (Time of Maximum Concentration in Plasma) of MP-424
Day 14 (Group A, B:10 cases)
|
2.45 hours
Interval 2.33 to 6.0
|
2.50 hours
Interval 2.42 to 5.75
|
|
Tmax (Time of Maximum Concentration in Plasma) of MP-424
Day 85 (Group A: 6 cases, Group B: 7 cases)
|
2.43 hours
Interval 2.33 to 4.0
|
3.24 hours
Interval 2.35 to 7.75
|
PRIMARY outcome
Timeframe: Data were collected at Day1 to Day85Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Outcome measures
| Measure |
Group B (MP-424 Low)
n=10 Participants
Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
Group A (MP-424 High)
n=10 Participants
Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
|---|---|---|
|
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424
Day 14 (Group A: 9 cases, Group B: 10 cases)
|
19.94 μg/mL
Standard Deviation 5.97
|
26.00 μg/mL
Standard Deviation 6.77
|
|
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424
Day 1 (Group A, B: 10 cases)
|
6.55 μg/mL
Standard Deviation 3.73
|
7.53 μg/mL
Standard Deviation 1.93
|
|
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424
Day 85 (Group A: 6 cases, Group B: 7 cases)
|
21.35 μg/mL
Standard Deviation 6.88
|
25.00 μg/mL
Standard Deviation 5.23
|
PRIMARY outcome
Timeframe: Data were collected at Day1 to Day85Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Outcome measures
| Measure |
Group B (MP-424 Low)
n=10 Participants
Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
Group A (MP-424 High)
n=10 Participants
Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
|---|---|---|
|
Ctrough (Minimum Observed Concentration in Plasma) of MP-424
Day1 (Group A,B: 10 cases)
|
0.681 μg/mL
Standard Deviation 0.412
|
0.846 μg/mL
Standard Deviation 0.500
|
|
Ctrough (Minimum Observed Concentration in Plasma) of MP-424
Day14 (Group A: 9 cases, Group B:10cases)
|
1.914 μg/mL
Standard Deviation 0.717
|
2.639 μg/mL
Standard Deviation 0.556
|
|
Ctrough (Minimum Observed Concentration in Plasma) of MP-424
Day85 (Group A: 6 cases, Group B:7cases)
|
2.105 μg/mL
Standard Deviation 0.819
|
2.679 μg/mL
Standard Deviation 0.355
|
PRIMARY outcome
Timeframe: Data were collected at Day1 to Day85Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85. Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Outcome measures
| Measure |
Group B (MP-424 Low)
n=10 Participants
Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
Group A (MP-424 High)
n=10 Participants
Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
|---|---|---|
|
T1/2(Time of Half-Life) of MP-424
Day1 (Group A: 7 cases, Group B: 8 cases)
|
4.03 hours
Standard Deviation 1.63
|
4.87 hours
Standard Deviation 2.12
|
|
T1/2(Time of Half-Life) of MP-424
Day14 (Group A: 8 cases, Group B: 9 cases)
|
10.00 hours
Standard Deviation 6.97
|
9.99 hours
Standard Deviation 4.37
|
|
T1/2(Time of Half-Life) of MP-424
Day85 (Group A: 6 cases, Group B: 7 cases)
|
6.22 hours
Standard Deviation 3.64
|
9.06 hours
Standard Deviation 3.98
|
SECONDARY outcome
Timeframe: 37 weeksHCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2-7.8 log10 IU/mL.
Outcome measures
| Measure |
Group B (MP-424 Low)
n=10 Participants
Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
Group A (MP-424 High)
n=10 Participants
Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
|---|---|---|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 253 (Group A: 6 cases, Group B: 6 cases)
|
-3.100 Log IU / mL
Standard Deviation 3.234
|
-1.883 Log IU / mL
Standard Deviation 3.177
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 1_4h (Group A,B: 10 cases)
|
-0.390 Log IU / mL
Standard Deviation 0.378
|
-0.420 Log IU / mL
Standard Deviation 0.264
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 1_8h (Group A,B: 10 cases)
|
-1.310 Log IU / mL
Standard Deviation 0.309
|
-1.300 Log IU / mL
Standard Deviation 0.294
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 1_16h (Group A,B: 10 cases)
|
-2.480 Log IU / mL
Standard Deviation 0.286
|
-2.350 Log IU / mL
Standard Deviation 0.458
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 2 (Group A,B: 10 cases)
|
-3.180 Log IU / mL
Standard Deviation 0.220
|
-3.010 Log IU / mL
Standard Deviation 0.340
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 3 (Group A,B: 10 cases)
|
-3.790 Log IU / mL
Standard Deviation 0.407
|
-3.610 Log IU / mL
Standard Deviation 0.453
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 8 (Group A,B: 10 cases)
|
-5.010 Log IU / mL
Standard Deviation 0.551
|
-4.840 Log IU / mL
Standard Deviation 0.622
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 14 (Group A,B: 10 cases)
|
-5.800 Log IU / mL
Standard Deviation 0.554
|
-5.570 Log IU / mL
Standard Deviation 0.579
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 29 (Group A: 10 cases, Group B: 9 cases)
|
-5.978 Log IU / mL
Standard Deviation 0.519
|
-5.860 Log IU / mL
Standard Deviation 0.611
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 43 (Group A: 8 cases, Group B: 8 cases)
|
-5.994 Log IU / mL
Standard Deviation 0.590
|
-6.000 Log IU / mL
Standard Deviation 0.573
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 57 (Group A: 7 cases, Group B: 8 cases)
|
-5.994 Log IU / mL
Standard Deviation 0.539
|
-5.986 Log IU / mL
Standard Deviation 0.538
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 86 (Group A: 6 cases, Group B: 7 cases)
|
-6.114 Log IU / mL
Standard Deviation 0.609
|
-6.000 Log IU / mL
Standard Deviation 0.588
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 92 (Group A: 6 cases, Group B: 7 cases)
|
-6.114 Log IU / mL
Standard Deviation 0.609
|
-6.000 Log IU / mL
Standard Deviation 0.588
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 99 (Group A: 6 cases, Group B: 7 cases)
|
-5.471 Log IU / mL
Standard Deviation 1.065
|
-6.000 Log IU / mL
Standard Deviation 0.588
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 113 (Group A: 6 cases, Group B: 7 cases)
|
-3.457 Log IU / mL
Standard Deviation 2.591
|
-5.917 Log IU / mL
Standard Deviation 0.564
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 141 (Group A: 6 cases, Group B: 7 cases)
|
-3.000 Log IU / mL
Standard Deviation 2.865
|
-4.233 Log IU / mL
Standard Deviation 2.455
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 169 (Group A: 6 cases, Group B: 6 cases)
|
-3.267 Log IU / mL
Standard Deviation 3.067
|
-3.100 Log IU / mL
Standard Deviation 2.827
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 197 (Group A: 6 cases, Group B: 6 cases)
|
-3.283 Log IU / mL
Standard Deviation 3.031
|
-2.850 Log IU / mL
Standard Deviation 2.947
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 225 (Group A: 6 cases, Group B: 6 cases)
|
-3.183 Log IU / mL
Standard Deviation 3.140
|
-2.633 Log IU / mL
Standard Deviation 2.748
|
|
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
Day 1_2.5h (Group A,B: 10 cases)
|
-0.220 Log IU / mL
Standard Deviation 0.329
|
-0.190 Log IU / mL
Standard Deviation 0.235
|
Adverse Events
Group A (MP-424 High)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Group B (MP-424 Low)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A (MP-424 High)
n=10 participants at risk
Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
Group B (MP-424 Low)
n=10 participants at risk
Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10
|
10.0%
1/10
|
|
Metabolism and nutrition disorders
Appetite disorders
|
0.00%
0/10
|
10.0%
1/10
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10
|
10.0%
1/10
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
1/10
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/10
|
10.0%
1/10
|
Other adverse events
| Measure |
Group A (MP-424 High)
n=10 participants at risk
Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
Group B (MP-424 Low)
n=10 participants at risk
Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
30.0%
3/10
|
40.0%
4/10
|
|
Blood and lymphatic system disorders
Anaemia
|
90.0%
9/10
|
80.0%
8/10
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
50.0%
5/10
|
20.0%
2/10
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
2/10
|
10.0%
1/10
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10
|
10.0%
1/10
|
|
Nervous system disorders
Headache
|
30.0%
3/10
|
70.0%
7/10
|
|
Nervous system disorders
Dysgeusia
|
30.0%
3/10
|
10.0%
1/10
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10
|
40.0%
4/10
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10
|
10.0%
1/10
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10
|
30.0%
3/10
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
2/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10
|
30.0%
3/10
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10
|
10.0%
1/10
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/10
|
10.0%
1/10
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10
|
50.0%
5/10
|
|
Gastrointestinal disorders
Abdominal discomfort
|
20.0%
2/10
|
30.0%
3/10
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10
|
30.0%
3/10
|
|
Gastrointestinal disorders
Stomatitis
|
30.0%
3/10
|
10.0%
1/10
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
1/10
|
10.0%
1/10
|
|
Gastrointestinal disorders
Proctalgia
|
10.0%
1/10
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Rash
|
70.0%
7/10
|
70.0%
7/10
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.0%
3/10
|
50.0%
5/10
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10
|
30.0%
3/10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10
|
20.0%
2/10
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/10
|
10.0%
1/10
|
|
General disorders
Pyrexia
|
60.0%
6/10
|
80.0%
8/10
|
|
General disorders
Malaise
|
60.0%
6/10
|
50.0%
5/10
|
|
General disorders
Influenza like illness
|
40.0%
4/10
|
20.0%
2/10
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/10
|
30.0%
3/10
|
|
Investigations
Blood uric acid increased
|
40.0%
4/10
|
40.0%
4/10
|
|
Investigations
Blood triglycerides increased
|
60.0%
6/10
|
50.0%
5/10
|
|
Investigations
Blood creatinine increased
|
50.0%
5/10
|
20.0%
2/10
|
|
Investigations
Blood lactate dehydrogenase increased
|
30.0%
3/10
|
70.0%
7/10
|
|
Investigations
Blood luteinising hormone increased
|
10.0%
1/10
|
20.0%
2/10
|
|
Investigations
Eosinophil percentage increased
|
10.0%
1/10
|
10.0%
1/10
|
|
Investigations
Lymphocyte percentage decreased
|
10.0%
1/10
|
10.0%
1/10
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/10
|
20.0%
2/10
|
|
Investigations
Platelet count decreased
|
100.0%
10/10
|
100.0%
10/10
|
|
Investigations
White blood cell count decreased
|
90.0%
9/10
|
100.0%
10/10
|
|
Investigations
Protein urine present
|
0.00%
0/10
|
10.0%
1/10
|
|
Investigations
Lymphocyte percentage increased
|
20.0%
2/10
|
20.0%
2/10
|
|
Investigations
Blood potassium decreased
|
20.0%
2/10
|
10.0%
1/10
|
|
Investigations
Neutrophil count decreased
|
20.0%
2/10
|
10.0%
1/10
|
|
Investigations
Basophil percentage decreased
|
20.0%
2/10
|
10.0%
1/10
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
2/10
|
0.00%
0/10
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
2/10
|
0.00%
0/10
|
|
Investigations
Blood bilirubin unconjugated increased
|
10.0%
1/10
|
20.0%
2/10
|
|
Investigations
Lipids abnormal
|
10.0%
1/10
|
20.0%
2/10
|
|
Investigations
Monocyte percentage increased
|
10.0%
1/10
|
20.0%
2/10
|
|
Investigations
Bilirubin conjugated increased
|
10.0%
1/10
|
10.0%
1/10
|
|
Investigations
Eosinophil percentage decreased
|
10.0%
1/10
|
10.0%
1/10
|
|
Investigations
Protein total decreased
|
0.00%
0/10
|
80.0%
8/10
|
|
Investigations
Blood albumin decreased
|
0.00%
0/10
|
30.0%
3/10
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/10
|
20.0%
2/10
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/10
|
10.0%
1/10
|
|
Infections and infestations
Cystitis
|
0.00%
0/10
|
10.0%
1/10
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/10
|
10.0%
1/10
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10
|
10.0%
1/10
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/10
|
10.0%
1/10
|
|
Gastrointestinal disorders
Frequent bowel movement
|
10.0%
1/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
10.0%
1/10
|
0.00%
0/10
|
|
General disorders
Injection site erythema
|
0.00%
0/10
|
10.0%
1/10
|
|
General disorders
Injection site reaction
|
10.0%
1/10
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/10
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10
|
10.0%
1/10
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10
|
10.0%
1/10
|
|
Nervous system disorders
Syncope
|
0.00%
0/10
|
10.0%
1/10
|
|
Psychiatric disorders
Affective disorder
|
10.0%
1/10
|
0.00%
0/10
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10
|
0.00%
0/10
|
|
Psychiatric disorders
Depression
|
10.0%
1/10
|
0.00%
0/10
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10
|
10.0%
1/10
|
|
Investigations
Blood calcium decreased
|
0.00%
0/10
|
10.0%
1/10
|
|
Investigations
Blood glucose increased
|
0.00%
0/10
|
10.0%
1/10
|
|
Investigations
Blood pressure decreased
|
0.00%
0/10
|
10.0%
1/10
|
|
Investigations
Blood pressure increased
|
10.0%
1/10
|
0.00%
0/10
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/10
|
10.0%
1/10
|
|
Investigations
C-reactive protein increased
|
10.0%
1/10
|
0.00%
0/10
|
|
Investigations
Eosinophil count increased
|
0.00%
0/10
|
10.0%
1/10
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/10
|
10.0%
1/10
|
|
Investigations
Reticulocyte count increased
|
0.00%
0/10
|
10.0%
1/10
|
|
Investigations
Neutrophil percentage decreased
|
30.0%
3/10
|
40.0%
4/10
|
|
Investigations
Neutrophil percentage increased
|
0.00%
0/10
|
10.0%
1/10
|
|
Investigations
Tri-iodothyronine free decreased
|
0.00%
0/10
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/10
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/10
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Skin discomfort
|
0.00%
0/10
|
10.0%
1/10
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10
|
0.00%
0/10
|
|
Vascular disorders
Hypotension
|
0.00%
0/10
|
10.0%
1/10
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/10
|
10.0%
1/10
|
|
Eye disorders
Eye discharge
|
0.00%
0/10
|
10.0%
1/10
|
|
Eye disorders
Visual impairment
|
0.00%
0/10
|
10.0%
1/10
|
|
Eye disorders
Eye pruritus
|
10.0%
1/10
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
10.0%
1/10
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
0.00%
0/10
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
10.0%
1/10
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10
|
0.00%
0/10
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10
|
10.0%
1/10
|
|
Renal and urinary disorders
Pollakiuria
|
10.0%
1/10
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
3/10
|
50.0%
5/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER