Trial Outcomes & Findings for Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer (NCT NCT01317641)
NCT ID: NCT01317641
Last Updated: 2017-03-29
Results Overview
A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE version 4.03\]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
136 participants
Primary outcome timeframe
Up to 28 days for each cohort
Results posted on
2017-03-29
Participant Flow
Participants were enrolled at 23 hospitals in Europe and in the USA from Apr 5, 2011 to Mar 12, 2013
136 participants participated in the study, including 24 enrolled in Phase 1 and 112 in Phase 2 randomly assigned to 200 mg, 400 mg or 1400 mg daily doses and stratified by previous chemotherapy and treatment with CYP17 inhibitor. Two participants assigned to treatment did not start ODM-201, and were therefore excluded from analyses populations.
Participant milestones
| Measure |
Phase 1: ODM-201 200 mg/Day
Dose escalation
|
Phase 1: ODM-201 400 mg/Day
Dose escalation
|
Phase 1: ODM-201 600 mg/Day
Dose escalation
|
Phase 1: ODM-201 1000 mg/Day
Dose escalation
|
Phase 1: ODM-201 1400 mg/Day
Dose escalation
|
Phase 1: ODM-201 1800 mg/Day
Dose escalation
|
Phase 2: ODM-201 200mg/Day
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
|
Phase 2: ODM-201 400mg/Day
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
|
Phase 2: ODM-201 1400mg/Day
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
3
|
4
|
3
|
3
|
38
|
38
|
36
|
|
Overall Study
COMPLETED
|
3
|
6
|
3
|
3
|
3
|
3
|
35
|
33
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
0
|
0
|
3
|
5
|
5
|
Reasons for withdrawal
| Measure |
Phase 1: ODM-201 200 mg/Day
Dose escalation
|
Phase 1: ODM-201 400 mg/Day
Dose escalation
|
Phase 1: ODM-201 600 mg/Day
Dose escalation
|
Phase 1: ODM-201 1000 mg/Day
Dose escalation
|
Phase 1: ODM-201 1400 mg/Day
Dose escalation
|
Phase 1: ODM-201 1800 mg/Day
Dose escalation
|
Phase 2: ODM-201 200mg/Day
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
|
Phase 2: ODM-201 400mg/Day
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
|
Phase 2: ODM-201 1400mg/Day
Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Not treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Disease progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Phase 1, 200mg/Day ODM-201
n=4 Participants
Dose escalation. Participants received twice daily of oral ODM-201 continuously.
|
Phase 1, 400mg/Day ODM-201
n=7 Participants
Dose escalation. Participants received twice daily of oral ODM-201 continuously.
|
Phase 1, 600mg/Day ODM-201
n=3 Participants
Dose escalation. Participants received twice daily of oral ODM-201 continuously.
|
Phase 1, 1000mg/Day ODM-201
n=4 Participants
Dose escalation. Participants received twice daily of oral ODM-201 continuously.
|
Phase 1, 1400mg/Day ODM-201
n=3 Participants
Dose escalation. Participants received twice daily of oral ODM-201 continuously.
|
Phase 1, 1800mg/Day ODM-201
n=3 Participants
Dose escalation. Participants received twice daily of oral ODM-201 continuously.
|
Phase 2 (200mg/Day ODM-201)
n=38 Participants
Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously
|
Phase 2 (400mg/Day ODM-201)
n=37 Participants
Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
|
Phase 2 (1400mg/Day ODM-201)
n=35 Participants
Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
71.9 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
67.7 years
STANDARD_DEVIATION 5.5 • n=21 Participants
|
67.7 years
STANDARD_DEVIATION 3.2 • n=10 Participants
|
68.3 years
STANDARD_DEVIATION 7.0 • n=115 Participants
|
69.1 years
STANDARD_DEVIATION 7.4 • n=24 Participants
|
71.3 years
STANDARD_DEVIATION 8.0 • n=42 Participants
|
69.4 years
STANDARD_DEVIATION 7.4 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
38 Participants
n=115 Participants
|
37 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
134 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days for each cohortPopulation: Safety population included all participants in Phase 1 who received any study drug.
A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE version 4.03\]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=4 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=7 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=4 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
PRIMARY outcome
Timeframe: Up to 28 days for each cohortPopulation: Safety population included all participants in Phase 1 who received any study drug.
The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=4 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=7 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=4 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Evaluable chemotherapy-naïve and CYP17i-naïve patients
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants who were naïve to both chemotherapy and CYP17 inhibitor
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=12 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=13 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=2 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=1 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=7 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
n=2 Participants
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group
|
6 participants
|
9 participants
|
1 participants
|
1 participants
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Evaluable post-chemotherapy and CYP17i-naïve patients
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with chemotherapy but not CYP17 inhibitor
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=11 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=9 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=1 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=1 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=11 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
n=1 Participants
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group
|
5 participants
|
1 participants
|
1 participants
|
1 participants
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Evaluable post-CYP17 inhibitor patients
Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with CYP17 inhibitor
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=15 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=17 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=1 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=15 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group
|
0 participants
|
3 participants
|
0 participants
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Evaluable Chemotherapy-naïve and CYP17i-naïve patients
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=9 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=9 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=2 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=2 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=2 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group
RECIST response CR+PR
|
1 participants
|
4 participants
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group
RECIST response CR+PR+SD
|
9 participants
|
6 participants
|
2 participants
|
2 participants
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Evaluable Post-chemotherapy and CYP17i-naïve patients
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=8 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=7 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=1 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=5 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=1 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group
RECIST response CR+PR
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group
RECIST response CR+PR+SD
|
5 participants
|
3 participants
|
0 participants
|
4 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Evaluable Post-CYP17i patients
Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=13 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=12 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=9 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group
RECIST response CR+PR
|
0 participants
|
2 participants
|
0 participants
|
—
|
—
|
—
|
|
Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group
RECIST response CR+PR+SD
|
5 participants
|
9 participants
|
6 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Evaluable chemotherapy-naïve and CYP17i-naïve patients with bone metastasis at baseline
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=11 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=10 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=1 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=7 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=1 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group
|
10 participants
|
7 participants
|
1 participants
|
6 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Evaluable Post-chemotherapy and CYP17i-naïve patients with bone metastasis at baseline
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=9 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=7 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=1 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=1 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=10 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group
|
5 participants
|
4 participants
|
1 participants
|
0 participants
|
7 participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Evaluable post-CYP17i patients with bone metastasis at baseline
Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=11 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=15 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=1 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=11 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group
|
5 participants
|
9 participants
|
1 participants
|
6 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdosePopulation: PK population (Day 8)
AUC(0-8h)
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=7 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state
|
6387.27 h*ng/mL
Standard Deviation 742.01
|
10973.66 h*ng/mL
Standard Deviation 5939.78
|
14205.99 h*ng/mL
Standard Deviation 2127.26
|
14817.39 h*ng/mL
Standard Deviation 4190.48
|
31764.82 h*ng/mL
Standard Deviation 8714.06
|
28884.44 h*ng/mL
Standard Deviation 4900.60
|
SECONDARY outcome
Timeframe: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdosePopulation: PK population (Day 8)
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=7 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state
|
1011.67 ng/mL
Standard Deviation 168.84
|
1757.57 ng/mL
Standard Deviation 858.72
|
2033.00 ng/mL
Standard Deviation 277.59
|
2392.33 ng/mL
Standard Deviation 406.63
|
4459.00 ng/mL
Standard Deviation 1163.10
|
4235.00 ng/mL
Standard Deviation 617.80
|
SECONDARY outcome
Timeframe: 1 dayPopulation: PK population (Day 1)
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=4 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=7 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=4 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1
|
3.00 h
Standard Deviation 1.63
|
3.00 h
Standard Deviation 0.73
|
3.00 h
Standard Deviation 0.92
|
5.08 h
Standard Deviation 1.47
|
3.00 h
Standard Deviation 1.15
|
5.00 h
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdosePopulation: PK population (Day 8)
AUC(0-8h)
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=7 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state
|
11754.23 h*ng/mL
Standard Deviation 5161.80
|
15501.56 h*ng/mL
Standard Deviation 2755.85
|
24902.56 h*ng/mL
Standard Deviation 12129.79
|
29980.83 h*ng/mL
Standard Deviation 11658.75
|
63531.81 h*ng/mL
Standard Deviation 15798.30
|
64435.97 h*ng/mL
Standard Deviation 22930.30
|
SECONDARY outcome
Timeframe: Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdosePopulation: PK population (Day 8)
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=7 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state
|
1850.00 ng/mL
Standard Deviation 654.83
|
2491.43 ng/mL
Standard Deviation 328.86
|
3963.33 ng/mL
Standard Deviation 1935.21
|
4643.33 ng/mL
Standard Deviation 1340.01
|
9336.67 ng/mL
Standard Deviation 2054.27
|
9406.67 ng/mL
Standard Deviation 3165.38
|
SECONDARY outcome
Timeframe: 1 dayPopulation: PK population (Day 1)
Outcome measures
| Measure |
Phase 1: ODM-201 200 mg/Day
n=4 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 400 mg/Day
n=7 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 600 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1000 mg/Day
n=4 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1400 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
Phase 1: ODM-201 1800 mg/Day
n=3 Participants
Participants received twice daily of oral ODM-201 continuously.
|
|---|---|---|---|---|---|---|
|
Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1
|
3.00 h
Standard Deviation 1.63
|
1.52 h
Standard Deviation 1.33
|
3.00 h
Standard Deviation 0.92
|
5.04 h
Standard Deviation 2.05
|
3.00 h
Standard Deviation 1.15
|
5.00 h
Standard Deviation 0.55
|
Adverse Events
Phase 1, 200mg/Day ODM-201
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1, 400mg/Day ODM-201
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1, 600mg/Day ODM-201
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 1, 1000mg/Day ODM-201
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1, 1400mg/Day ODM-201
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1, 1800mg/Day ODM-201
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 2, 200mg/Day ODM-201
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Phase 2, 400mg/Day ODM-201
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Phase 2, 1400mg/Day ODM-201
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1, 200mg/Day ODM-201
n=4 participants at risk
Dose escalation
|
Phase 1, 400mg/Day ODM-201
n=7 participants at risk
Dose escalation
|
Phase 1, 600mg/Day ODM-201
n=3 participants at risk
Dose escalation
|
Phase 1, 1000mg/Day ODM-201
n=4 participants at risk
Dose escalation
|
Phase 1, 1400mg/Day ODM-201
n=3 participants at risk
Dose escalation
|
Phase 1, 1800mg/Day ODM-201
n=3 participants at risk
Dose escalation
|
Phase 2, 200mg/Day ODM-201
n=38 participants at risk
Dose expansion
|
Phase 2, 400mg/Day ODM-201
n=37 participants at risk
Dose expansion
|
Phase 2, 1400mg/Day ODM-201
n=35 participants at risk
Dose expansion
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
General disorders
Fatigue
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
1/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Infections and infestations
Liver abscess
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
1/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
1/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
Other adverse events
| Measure |
Phase 1, 200mg/Day ODM-201
n=4 participants at risk
Dose escalation
|
Phase 1, 400mg/Day ODM-201
n=7 participants at risk
Dose escalation
|
Phase 1, 600mg/Day ODM-201
n=3 participants at risk
Dose escalation
|
Phase 1, 1000mg/Day ODM-201
n=4 participants at risk
Dose escalation
|
Phase 1, 1400mg/Day ODM-201
n=3 participants at risk
Dose escalation
|
Phase 1, 1800mg/Day ODM-201
n=3 participants at risk
Dose escalation
|
Phase 2, 200mg/Day ODM-201
n=38 participants at risk
Dose expansion
|
Phase 2, 400mg/Day ODM-201
n=37 participants at risk
Dose expansion
|
Phase 2, 1400mg/Day ODM-201
n=35 participants at risk
Dose expansion
|
|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
11.4%
4/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
1/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Investigations
Cardiac murmur
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Investigations
Urine output increased
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
1/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
7.9%
3/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
10.8%
4/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
1/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
13.2%
5/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
16.2%
6/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.7%
2/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
3/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
1/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
66.7%
2/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
10.8%
4/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
10.5%
4/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
10.8%
4/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
8.6%
3/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
General disorders
Fatigue
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
18.4%
7/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
21.6%
8/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
5/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
General disorders
Oedema peripheral
|
50.0%
2/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.3%
2/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
11.4%
4/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
General disorders
Pain
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
7.9%
3/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
13.5%
5/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
11.4%
4/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Investigations
Weight decreased
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
1/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
5/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
7.9%
3/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
8.1%
3/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
5/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
7.9%
3/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
10.8%
4/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.7%
2/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
13.2%
5/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
16.2%
6/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
11.4%
4/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
10.5%
4/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.4%
2/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
8.6%
3/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.3%
2/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
10.8%
4/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.7%
2/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.3%
2/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
10.8%
4/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.7%
2/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
2/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
8.1%
3/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
8.6%
3/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
General disorders
Asthenia
|
50.0%
2/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
28.6%
2/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
General disorders
Chest pain
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
8.1%
3/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.7%
2/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.4%
2/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.7%
2/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.4%
2/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.3%
2/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.7%
2/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.4%
2/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.7%
2/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.3%
2/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
8.6%
3/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
2/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
7.9%
3/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
66.7%
2/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.4%
2/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.4%
2/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
5.7%
2/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Eye disorders
Eye pruritus
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Eye disorders
Visual acuity reduced
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
1/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
General disorders
Pyrexia
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
1/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
1/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
1/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
14.3%
1/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
25.0%
1/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/7 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
33.3%
1/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/4 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
0.00%
0/3 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.6%
1/38 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.7%
1/37 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
2.9%
1/35 • 3 months
Phase 1 dose escalation and Phase 2 per dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER