Trial Outcomes & Findings for A Study of TAK-105 in Healthy Adults (NCT NCT04964258)
NCT ID: NCT04964258
Last Updated: 2024-08-02
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after the first dose of the study treatment and last dose of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
Results posted on
2024-08-02
Participant Flow
Healthy participants took part in the study at 3 investigative sites in the United States from 26 July 2021 to 20 June 2023. The study consisted of six parts: Participants were enrolled into Part 1 and Part 2 of the study. Study was completed after Parts 1 and 2. Sponsor decided not to conduct Part 3, 4, 5, and 6 after comprehensive review of available data.
Participants were randomized in Parts 1 and 2 to receive of either TAK-105 or matching-placebo.
Participant milestones
| Measure |
Part 1: Placebo
TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 1
TAK-105-a Dose 1, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 2
TAK-105-a Dose 2, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 3
TAK-105-a Dose 3, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 4
TAK-105-a Dose 4, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 5
TAK-105-a Dose 5, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 6
TAK-105-a Dose 6, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 7
TAK-105-a Dose 7, injection, subcutaneously, once on Day 1.
|
Part 2: Placebo
TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks.
|
Part 2: TAK-105 Dose 1A
TAK-105-a Dose 1A, injection, subcutaneously, once weekly for 2 and 4 weeks.
|
Part 2: TAK-105 Dose 2A
TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
6
|
|
Overall Study
COMPLETED
|
13
|
6
|
6
|
6
|
6
|
5
|
6
|
6
|
6
|
12
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: Placebo
TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 1
TAK-105-a Dose 1, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 2
TAK-105-a Dose 2, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 3
TAK-105-a Dose 3, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 4
TAK-105-a Dose 4, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 5
TAK-105-a Dose 5, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 6
TAK-105-a Dose 6, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 7
TAK-105-a Dose 7, injection, subcutaneously, once on Day 1.
|
Part 2: Placebo
TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks.
|
Part 2: TAK-105 Dose 1A
TAK-105-a Dose 1A, injection, subcutaneously, once weekly for 2 and 4 weeks.
|
Part 2: TAK-105 Dose 2A
TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of TAK-105 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Part 1: Placebo
n=14 Participants
TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 1
n=6 Participants
TAK-105-a Dose 1, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 2
n=6 Participants
TAK-105-a Dose 2, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 3
n=6 Participants
TAK-105-a Dose 3, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 4
n=6 Participants
TAK-105-a Dose 4, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 5
n=6 Participants
TAK-105-a Dose 5, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 6
n=6 Participants
TAK-105-a Dose 6, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 7
n=6 Participants
TAK-105-a Dose 7, injection, subcutaneously, once on Day 1.
|
Part 2: Placebo
n=6 Participants
TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks.
|
Part 2: TAK-105 Dose 1A
n=12 Participants
TAK-105-a Dose 1A, injection, subcutaneously, once weekly for 2 and 4 weeks.
|
Part 2: TAK-105 Dose 2A
n=6 Participants
TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
12 Participants
n=62 Participants
|
6 Participants
n=95 Participants
|
80 Participants
n=129 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
12 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
9 Participants
n=62 Participants
|
6 Participants
n=95 Participants
|
68 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
8 Participants
n=62 Participants
|
5 Participants
n=95 Participants
|
42 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
38 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
3 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
18 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
11 Participants
n=62 Participants
|
5 Participants
n=95 Participants
|
59 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
12 Participants
n=62 Participants
|
6 Participants
n=95 Participants
|
80 Participants
n=129 Participants
|
PRIMARY outcome
Timeframe: Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82Population: Safety analysis set included all participants who were randomized and received at least 1 dose of study treatment.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after the first dose of the study treatment and last dose of study treatment.
Outcome measures
| Measure |
Part 1: Placebo
n=14 Participants
TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 1
n=6 Participants
TAK-105-a Dose 1, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 2
n=6 Participants
TAK-105-a Dose 2, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 3
n=6 Participants
TAK-105-a Dose 3, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 4
n=6 Participants
TAK-105-a Dose 4, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 5
n=6 Participants
TAK-105-a Dose 5, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 6
n=6 Participants
TAK-105-a Dose 6, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 7
n=6 Participants
TAK-105-a Dose 7, injection, subcutaneously, once on Day 1.
|
Part 2: Placebo
n=6 Participants
TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks.
|
Part 2: TAK-105 Dose 1A
n=12 Participants
TAK-105-a Dose 1A, injection, subcutaneously, once weekly for 2 and 4 weeks.
|
Part 2: TAK-105 Dose 2A
n=6 Participants
TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With At Least One Treatment-emergent Adverse Event (TEAEs)
|
6 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82Population: Immunogenicity analysis set included all participants who received at least 1 dose of study treatment and had the baseline sample and at least 1 postbaseline sample ADA assessment. Here, "number analyzed" signifies participants who were evaluable for specified categories.
ADA included ADA-negative or transiently and persistently ADA-positive, and low or high ADA titer assessment. ADA negative was defined as participants who did not have a confirmed positive ADA status in any postbaseline assessment. Transiently ADA positive was defined as participants who had confirmed positive ADA status in 1 or 2 postbaseline assessments. Persistently ADA positive was defined as participants who had confirmed positive ADA status in more than 2 postbaseline assessments. For ADA positive (transiently ADA positive or persistently ADA positive) only, high ADA titer was defined as participant who has at least 1 postbaseline ADA titer greater than (\>) 16; low ADA titer was defined as participant whose postbaseline ADA titers were all less than or equal to (\<=) 16. ADA titer was assessed in ADA-positive participants.
Outcome measures
| Measure |
Part 1: Placebo
n=14 Participants
TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 1
n=6 Participants
TAK-105-a Dose 1, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 2
n=6 Participants
TAK-105-a Dose 2, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 3
n=6 Participants
TAK-105-a Dose 3, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 4
n=6 Participants
TAK-105-a Dose 4, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 5
n=6 Participants
TAK-105-a Dose 5, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 6
n=6 Participants
TAK-105-a Dose 6, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 7
n=6 Participants
TAK-105-a Dose 7, injection, subcutaneously, once on Day 1.
|
Part 2: Placebo
n=6 Participants
TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks.
|
Part 2: TAK-105 Dose 1A
n=12 Participants
TAK-105-a Dose 1A, injection, subcutaneously, once weekly for 2 and 4 weeks.
|
Part 2: TAK-105 Dose 2A
n=6 Participants
TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Based on Antidrug Antibody (ADA) Status
ADA Negative
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
|
Number of Participants Based on Antidrug Antibody (ADA) Status
Persistently ADA Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Based on Antidrug Antibody (ADA) Status
Transiently ADA Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Part 1: Day 1 pre-dose and at multiple timepoints (up to Day 60) post-dose; Part 2: Day 1 pre-dose and at multiple timepoints (up to Day 6) post-dose; Part 2: Day 22 pre-dose and at multiple timepoints (up to Day 82) post-dosePopulation: PK analysis set included all participants who received at least 1 dose of TAK-105 and had at least 1 measurable post-dose plasma or urine concentration for TAK-105. As per-planned analysis, for PK assessment, participants in the Dose 1A arm group were divided and analyzed into two separate groups based on the number of Dose 1A doses received (i.e., who received all 4 doses' and 'who received 2 doses).
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Part 1: Day 1 pre-dose and at multiple timepoints (up to Day 60) post-dosePopulation: PK analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Data was not planned to be analyzed for Part 2
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Part 1: Day 1 pre-dose and at multiple timepoints (up to Day 60) post-dosePopulation: PK analysis set. Data was not planned to be analyzed for Part 2.
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Part 1: Day 1 pre-dose and at multiple timepoints (up to Day 60) post-dose; Part 2: Day 1 pre-dose and at multiple timepoints (up to Day 6) post-dose; Part 2: Day 22 pre-dose and at multiple timepoints (up to Day 82) post-dosePopulation: PK analysis set. As per-planned analysis, for PK assessment, participants in the Dose 1A arm group were divided and analyzed into two separate groups based on the number of Dose 1A doses received (i.e., who received all 4 doses' and 'who received 2 doses).
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Part 1: Day 1 pre-dose and at multiple timepoints (up to Day 60) post-dose; Part 2: Day 1 pre-dose and at multiple timepoints (up to Day 6) post-dose; Part 2: Day 22 pre-dose and at multiple timepoints (up to Day 82) post-dosePopulation: PK analysis set. As per-planned analysis, for PK assessment, participants in the Dose 1A arm group were divided and analyzed into two separate groups based on the number of Dose 1A doses received (i.e., who received all 4 doses' and 'who received 2 doses). Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Part 1: Day 1 pre-dose and at multiple timepoints (up to Day 60) post-dose; Part 2: Day 22 pre-dose and at multiple timepoints (up to Day 82) post-dosePopulation: PK analysis set. As per-planned analysis, for PK assessment, participants in the Dose 1A arm group were divided and analyzed into two separate groups based on the number of Dose 1A doses received (i.e., who received all 4 doses' and 'who received 2 doses). Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Part 1: Day 1 pre-dose and at multiple timepoints (up to Day 60) post-dose; Part 2: Day 22 pre-dose and at multiple timepoints (up to Day 82) post-dosePopulation: PK analysis set. As per-planned analysis, for PK assessment, participants in the Dose 1A arm group were divided and analyzed into two separate groups based on the number of Dose 1A doses received (i.e., who received all 4 doses' and 'who received 2 doses). Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Part 2: Day 1 pre-dose and at multiple timepoints (up to Day 6) post-dose; Day 22 pre-dose and at multiple timepoints (up to Day 82) post-dosePopulation: PK analysis set. Data was not planned to be analyzed for Part 1. As per-planned analysis, for PK assessment, participants in the Dose 1A arm group were divided and analyzed into two separate groups based on the number of Dose 1A doses received (i.e., who received all 4 doses' and 'who received 2 doses). Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Part 2: Day 22 pre-dose and at multiple timepoints (up to Day 82) post-dosePopulation: PK analysis set. Data was not planned to be analyzed for Part 1. As per-planned analysis, for PK assessment, participants in the Dose 1A arm group were divided and analyzed into two separate groups based on the number of Dose 1A doses received (i.e., who received all 4 doses' and 'who received 2 doses). Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Parts 1 and 2: Day 1 pre-dose and at multiple time points (up to Day 8) post-dose; Part 2: Day 22 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: PK analysis set. As per-planned analysis, for PK assessment, participants in the Dose 1A arm group were divided and analyzed into two separate groups based on the number of Dose 1A doses received (i.e., Who received all 4 doses' and 'who received 2 doses). Here, "overall number of participants analyzed" signifies participants evaluable for this outcome. Data of urine PK parameter could not be calculated as all samples were below the lower limit of quantification (LLOQ) values in Parts 1 and 2.
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Parts 1 and 2: Day 1 pre-dose and at multiple time points (up to Day 8) post-dose; Part 2: Day 22 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: PK analysis set. As per-planned analysis, for PK assessment, participants in the Dose 1A arm group were divided and analyzed into two separate groups based on the number of Dose 1A doses received (i.e., Who received all 4 doses' and 'who received 2 doses). Here, "overall number of participants analyzed" signifies participants evaluable for this outcome. Data of urine PK parameter could not be calculated as all samples were below the LLOQ values in Parts 1 and 2.
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Parts 1 and 2: Day 1 pre-dose and at multiple time points (up to Day 8) post-dose; Part 2: Day 22 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: PK analysis set. As per-planned analysis, for PK assessment, participants in the Dose 1A arm group were divided and analyzed into two separate groups based on the number of Dose 1A doses received (i.e., Who received all 4 doses' and 'who received 2 doses). Here, "overall number of participants analyzed" signifies participants evaluable for this outcome. Data of urine PK parameter could not be calculated as all samples were below the LLOQ values in Parts 1 and 2.
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Parts 1 and 2: Day 1 pre-dose and at multiple time points (up to Day 8) post-dose; Part 2: Day 22 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: PK analysis set. As per-planned analysis, for PK assessment, participants in the Dose 1A arm group were divided and analyzed into two separate groups based on the number of Dose 1A doses received (i.e., Who received all 4 doses' and 'who received 2 doses). Here, "overall number of participants analyzed" signifies participants evaluable for this outcome. Data of urine PK parameter could not be calculated as all samples were below the LLOQ values in Parts 1 and 2.
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Parts 1 and 2: Day 1 pre-dose and at multiple time points (up to Day 8) post-dose; Part 2: Day 22 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: PK analysis set. As per-planned analysis, for PK assessment, participants in the Dose 1A arm group were divided and analyzed into two separate groups based on the number of Dose 1A doses received (i.e., Who received all 4 doses' and 'who received 2 doses). Here, "overall number of participants analyzed" signifies participants evaluable for this outcome. Data of urine PK parameter could not be calculated as all samples were below the LLOQ values in Parts 1 and 2.
Due to confidentiality reasons and chances of exposing the doses for TAK-105, the data for this pharmacokinetic outcome measure was not reported.
Outcome measures
Outcome data not reported
Adverse Events
Part 1: Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1: TAK-105 Dose 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: TAK-105 Dose 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: TAK-105 Dose 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: TAK-105 Dose 4
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: TAK-105 Dose 5
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: TAK-105 Dose 6
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: TAK-105 Dose 7
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2: Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: TAK-105 Dose 1A
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 2: TAK-105 Dose 2A
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Placebo
n=14 participants at risk
TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 1
n=6 participants at risk
TAK-105-a Dose 1, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 2
n=6 participants at risk
TAK-105-a Dose 2, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 3
n=6 participants at risk
TAK-105-a Dose 3, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 4
n=6 participants at risk
TAK-105-a Dose 4, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 5
n=6 participants at risk
TAK-105-a Dose 5, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 6
n=6 participants at risk
TAK-105-a Dose 6, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 7
n=6 participants at risk
TAK-105-a Dose 7, injection, subcutaneously, once on Day 1.
|
Part 2: Placebo
n=6 participants at risk
TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks.
|
Part 2: TAK-105 Dose 1A
n=12 participants at risk
TAK-105-a Dose 1A, injection, subcutaneously, once weekly for 2 and 4 weeks.
|
Part 2: TAK-105 Dose 2A
n=6 participants at risk
TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Part 1: Placebo
n=14 participants at risk
TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 1
n=6 participants at risk
TAK-105-a Dose 1, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 2
n=6 participants at risk
TAK-105-a Dose 2, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 3
n=6 participants at risk
TAK-105-a Dose 3, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 4
n=6 participants at risk
TAK-105-a Dose 4, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 5
n=6 participants at risk
TAK-105-a Dose 5, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 6
n=6 participants at risk
TAK-105-a Dose 6, injection, subcutaneously, once on Day 1.
|
Part 1: TAK-105 Dose 7
n=6 participants at risk
TAK-105-a Dose 7, injection, subcutaneously, once on Day 1.
|
Part 2: Placebo
n=6 participants at risk
TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks.
|
Part 2: TAK-105 Dose 1A
n=12 participants at risk
TAK-105-a Dose 1A, injection, subcutaneously, once weekly for 2 and 4 weeks.
|
Part 2: TAK-105 Dose 2A
n=6 participants at risk
TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
2/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
2/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Electrocardiogram T wave inversion
|
7.1%
1/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
7.1%
1/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
2/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Hunger
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
2/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Medical device site dermatitis
|
14.3%
2/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
4/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
4/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
6/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Medical device site erythema
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Medical device site irritation
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Medical device site papule
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Medical device site pruritus
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Medical device site reaction
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Medical device site vesicles
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Palpitations
|
7.1%
1/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Tachycardia
|
21.4%
3/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
3/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
3/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
41.7%
5/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.3%
1/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/14 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/12 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER