Trial Outcomes & Findings for A Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) for TAK-906 in Participants With Diabetes Mellitus and Gastroparesis (DG) or With Idiopathic Gastroparesis (IG) (NCT NCT03268941)
NCT ID: NCT03268941
Last Updated: 2021-01-06
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 (e.g., 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any following reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Results posted on
2021-01-06
Participant Flow
Participants took part in the study at 7 investigative sites in the United States from 26 September 2017 to 09 March 2018.
Participants with a diagnosis of diabetes mellitus and gastroparesis (GP) or with idiopathic gastroparesis (IG) were enrolled. 51 participants were randomized in Part 1, out of which 48 completed the Part 1, 21 of 48 participants entered the Part 2.
Participant milestones
| Measure |
Part 1: Placebo
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Under Fed Conditions
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) followed by fasted condition. There was a minimum 7- day washout period between the two conditions.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Part 1 (Days 1 to 9)
STARTED
|
12
|
14
|
12
|
13
|
0
|
0
|
0
|
|
Part 1 (Days 1 to 9)
COMPLETED
|
11
|
14
|
12
|
11
|
0
|
0
|
0
|
|
Part 1 (Days 1 to 9)
NOT COMPLETED
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Part 2: Days 17 to 25
STARTED
|
0
|
0
|
0
|
0
|
6
|
0
|
15
|
|
Part 2: Days 17 to 25
Treated
|
0
|
0
|
0
|
0
|
6
|
0
|
13
|
|
Part 2: Days 17 to 25
COMPLETED
|
0
|
0
|
0
|
0
|
6
|
0
|
13
|
|
Part 2: Days 17 to 25
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Part 2: Period 2: Fasted (Day 25)
STARTED
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
|
Part 2: Period 2: Fasted (Day 25)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
|
Part 2: Period 2: Fasted (Day 25)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: Placebo
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Under Fed Conditions
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) followed by fasted condition. There was a minimum 7- day washout period between the two conditions.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Part 1 (Days 1 to 9)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1 (Days 1 to 9)
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1 (Days 1 to 9)
Protocol Deviation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Days 17 to 25
Reason not specified
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 2: Days 17 to 25
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) for TAK-906 in Participants With Diabetes Mellitus and Gastroparesis (DG) or With Idiopathic Gastroparesis (IG)
Baseline characteristics by cohort
| Measure |
Part 1: Placebo
n=12 Participants
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=14 Participants
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=12 Participants
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
n=13 Participants
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 13.84 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 11.75 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 17.13 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 10.19 • n=4 Participants
|
53.4 years
STANDARD_DEVIATION 13.14 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic and Latino
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Height
|
164.62 cm
STANDARD_DEVIATION 9.790 • n=5 Participants
|
163.95 cm
STANDARD_DEVIATION 6.751 • n=7 Participants
|
164.56 cm
STANDARD_DEVIATION 7.204 • n=5 Participants
|
164.93 cm
STANDARD_DEVIATION 9.778 • n=4 Participants
|
164.50 cm
STANDARD_DEVIATION 8.212 • n=21 Participants
|
|
Weight
|
74.70 kg
STANDARD_DEVIATION 17.231 • n=5 Participants
|
79.86 kg
STANDARD_DEVIATION 13.470 • n=7 Participants
|
80.55 kg
STANDARD_DEVIATION 11.346 • n=5 Participants
|
88.24 kg
STANDARD_DEVIATION 11.803 • n=4 Participants
|
80.95 kg
STANDARD_DEVIATION 14.064 • n=21 Participants
|
|
Body Mass Index (BMI)
|
27.282 kg/m^2
STANDARD_DEVIATION 4.2276 • n=5 Participants
|
29.679 kg/m^2
STANDARD_DEVIATION 4.5043 • n=7 Participants
|
29.832 kg/m^2
STANDARD_DEVIATION 4.5461 • n=5 Participants
|
32.565 kg/m^2
STANDARD_DEVIATION 4.4001 • n=4 Participants
|
29.887 kg/m^2
STANDARD_DEVIATION 4.6805 • n=21 Participants
|
|
Underlying Disease
Diabetic Gastroparesis (DG)
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Underlying Disease
Idiopathic Gastroparesis (IG)
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)Population: SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part.
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 (e.g., 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any following reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
Outcome measures
| Measure |
Part 1: Placebo
n=12 Participants
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=14 Participants
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=12 Participants
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
n=13 Participants
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
n=6 Participants
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
n=6 Participants
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
n=13 Participants
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced At Least One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Experienced At Least One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 14 days after the last dose of study drug in Part 1 (Up to approximately 23 days)Population: SAS included all participants who were randomized and received at least 1 dose of study drug in the Part 1. Laboratory assessment were performed only in Part 1 of the study. Number analyzed are participants with data available for the particular parameter.
Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as:alanine aminotransferase (ALT)\>3.0 U/L\*upper limit of normal(ULN),albumin\<25 g/L\*lower limit of normal(LLN),alkaline phosphatase \>3.0 U/L\*ULN,aspartate aminotransferase \>3.0 U/L\*ULN,bilirubin \>2 umol/L\*ULN,blood urea nitrogen(BUN) \>10.7 mmol/L,calcium \<1.75 mmol/L, \>2.88 mmol/L,chloride \<75 mmol/L, \>126 mmol/L,creatinine \>177umol/L,gamma glutamyl transferase (GGT) \>3 U/L\*ULN,glucose \<2.8 mmol/L, \>19.4 mmol/L,phosphate \<0.52 mmol/L, \>2.10 mmol/L,potassium\<3 mmol/L, \>6 mmol/L,sodium \<130 mmol/L, \>150 mmol/L,hematocrit (%) \<0.8\*LLN, \>1.2\*ULN,hemoglobin \<0.8 g/L\*LLN, \>1.2 g/L\*ULN,leukocytes \<0.5 (10\^9/L)\*LLN, \>1.5 (10\^9/L)\*ULN,erythrocytes\<0.8 (10\^12/L)\*LLN, \>1.2(10\^12/L)\*ULN,platelets \<75(10\^9/L), \>600(10\^9/L). Participants with at least 1 markedly abnormal laboratory parameter value is reported.
Outcome measures
| Measure |
Part 1: Placebo
n=12 Participants
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=14 Participants
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=12 Participants
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
n=13 Participants
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Hematocrit (%)<0.8 x LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Hemoglobin (g/L) <0.8 x LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
ALT >3.0 U/Lx ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
AST >3.0 U/L x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
BUN >10.7 mmol/L
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Calcium >2.88 mmol/L
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
GGT >3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Laboratory Parameters Values
Sodium (mmol/L) <130 mmol/L
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)Population: SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part.
Vital signs included body temperature, diastolic and systolic blood pressure (mmHg), and heart rate (beats per minute \[bpm\]). Heart rate\<50 bpm and systolic blood pressure \<85 mmHg were considered markedly abnormal.
Outcome measures
| Measure |
Part 1: Placebo
n=12 Participants
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=14 Participants
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=12 Participants
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
n=13 Participants
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
n=6 Participants
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
n=6 Participants
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
n=13 Participants
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Markedly Abnormal Vital Signs
Heart Rate (bpm) <50
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Vital Signs
Systolic Blood Pressure (mmHg) <85
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)Population: SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part.
The 12-lead electrocardiogram (ECG) values outside the range Heart Rate \<50 (beats/min), PR Interval ≤120 (msec), PR Interval ≥200 (msec), QRS Duration ≥120 (msec), QT Interval ≥460 (msec) were considered markedly abnormal.
Outcome measures
| Measure |
Part 1: Placebo
n=12 Participants
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=14 Participants
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=12 Participants
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
n=13 Participants
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
n=6 Participants
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
n=6 Participants
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
n=13 Participants
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values
Heart Rate (bpm) <50
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values
PR Interval (msec) ≤120
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values
PR Interval (msec) ≥200
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values
QRS Duration (msec) ≥120
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values
QT Interval (msec) ≥460
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 predose (Baseline), 1 hour and at multiple timepoints (Up to 8 hours) postdosePopulation: Full analysis set (FAS) included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for at least one of pharmacodynamic (PD) measurement. Overall number of participants analyzed are participants with evaluable data for this outcome measure.
Change in serum prolactin on Day 1 at the Tmax, time of first occurrence of maximum serum concentration (Cmax) relative to Baseline was calculated as a ratio of maximum serum prolactin concentration on Day 1 to serum prolactin concentration at Baseline.
Outcome measures
| Measure |
Part 1: Placebo
n=12 Participants
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=14 Participants
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=11 Participants
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
n=13 Participants
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Serum Prolactin Concentration on Day 1 at Tmax, Time of First Occurrence of Maximum Serum Concentration (Cmax) for TAK-906 Maleate for Part 1
|
1.54 ratio
Standard Deviation 0.704
|
12.77 ratio
Standard Deviation 9.102
|
19.92 ratio
Standard Deviation 13.604
|
20.07 ratio
Standard Deviation 9.170
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for assessment of at least one of the PD measurement. Overall number of participants analyzed are the participants with evaluable data for this outcome measure.
The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.
Outcome measures
| Measure |
Part 1: Placebo
n=11 Participants
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=14 Participants
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=11 Participants
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
n=13 Participants
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time as Measured by the 13C Spirulina GEBT Following Multiple Dose Administration of TAK-906 Maleate on Day 7 for Part 1
Baseline
|
118.74 min
Standard Deviation 43.106
|
130.18 min
Standard Deviation 35.316
|
121.26 min
Standard Deviation 33.606
|
122.50 min
Standard Deviation 31.803
|
—
|
—
|
—
|
|
Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time as Measured by the 13C Spirulina GEBT Following Multiple Dose Administration of TAK-906 Maleate on Day 7 for Part 1
Change from Baseline at Day 7
|
4.55 min
Standard Deviation 16.332
|
6.21 min
Standard Deviation 36.986
|
7.80 min
Standard Deviation 52.946
|
7.72 min
Standard Deviation 24.609
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 1 of Part 1Population: FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline at least 1 valid postbaseline value for assessment of at least one PD measurement. Overall number of participants analyzed are participants with evaluable data for this outcome measure.
The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.
Outcome measures
| Measure |
Part 1: Placebo
n=11 Participants
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=14 Participants
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=11 Participants
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
n=13 Participants
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time Following Single Dose Administration of TAK-906 Maleate as Measured by the 13C Spirulina GEBT on Day 1
Baseline
|
118.74 minute (min)
Standard Deviation 43.106
|
130.18 minute (min)
Standard Deviation 35.316
|
121.26 minute (min)
Standard Deviation 33.606
|
122.50 minute (min)
Standard Deviation 31.803
|
—
|
—
|
—
|
|
Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time Following Single Dose Administration of TAK-906 Maleate as Measured by the 13C Spirulina GEBT on Day 1
Change from Baseline at Day 1
|
-5.71 minute (min)
Standard Deviation 21.687
|
0.12 minute (min)
Standard Deviation 21.736
|
6.74 minute (min)
Standard Deviation 44.390
|
0.71 minute (min)
Standard Deviation 21.192
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for assessment of at least one of the PD measurements. Overall number of participants analyzed is number of participants with evaluable data for this outcome measure.
SmartPill is an ingestible capsule that measures pressure, potential of hydrogen (pH) and temperature as it travels through the gastrointestinal (GI) tract to assess GE and GI motility. SmartPill eliminates radiation exposure and is the only motility test that provides a complete transit profile of the GI tract.
Outcome measures
| Measure |
Part 1: Placebo
n=8 Participants
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=10 Participants
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=9 Participants
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
n=8 Participants
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Gastric Emptying (GE) Time as Measured by the SmartPill on Day 7 for Part 1
|
124.62 percent change in GE time
Standard Deviation 181.125
|
61.72 percent change in GE time
Standard Deviation 195.867
|
419.27 percent change in GE time
Standard Deviation 885.362
|
71.09 percent change in GE time
Standard Deviation 121.584
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdosePopulation: Pharmacokinetic (PK) set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of AUCt. Number analyzed are participants with evaluable data at given time-point.
Outcome measures
| Measure |
Part 1: Placebo
n=13 Participants
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=11 Participants
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=12 Participants
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
AUCτ: Area Under the Plasma Concentration-time Curve From 0 to Time (T) Over the Dosing Interval for TAK-906 in Part 1
Day 1
|
4.67 h*ng/mL
Standard Deviation 1.69
|
23.0 h*ng/mL
Standard Deviation 7.76
|
131 h*ng/mL
Standard Deviation 44.8
|
—
|
—
|
—
|
—
|
|
AUCτ: Area Under the Plasma Concentration-time Curve From 0 to Time (T) Over the Dosing Interval for TAK-906 in Part 1
Day 7
|
5.46 h*ng/mL
Standard Deviation 2.07
|
26.3 h*ng/mL
Standard Deviation 11.3
|
166 h*ng/mL
Standard Deviation 93.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdosePopulation: PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Cmax. Number analyzed are participants with evaluable data at given time-point.
Outcome measures
| Measure |
Part 1: Placebo
n=13 Participants
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=11 Participants
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=13 Participants
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK 906 in Part 1
Day 1
|
2.27 ng/mL
Standard Deviation 0.819
|
12.0 ng/mL
Standard Deviation 5.36
|
75.7 ng/mL
Standard Deviation 39.9
|
—
|
—
|
—
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for TAK 906 in Part 1
Day 7
|
2.87 ng/mL
Standard Deviation 1.78
|
15.5 ng/mL
Standard Deviation 5.58
|
99.6 ng/mL
Standard Deviation 69.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Predose on Days 2, 3, 4, 5, 6, 7, 8 and 9Population: PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Ctrough. Number analyzed are participants with evaluable data at given time-point.
Outcome measures
| Measure |
Part 1: Placebo
n=13 Participants
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=11 Participants
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=13 Participants
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1
Predose on Day 2
|
0.0121 ng/mL
Standard Deviation 0.0315
|
0.262 ng/mL
Standard Deviation 0.349
|
0.770 ng/mL
Standard Deviation 0.513
|
—
|
—
|
—
|
—
|
|
Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1
Predose on Day 3
|
0.0423 ng/mL
Standard Deviation 0.0527
|
0.503 ng/mL
Standard Deviation 0.640
|
0.958 ng/mL
Standard Deviation 0.750
|
—
|
—
|
—
|
—
|
|
Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1
Predose on Day 4
|
0.0178 ng/mL
Standard Deviation 0.0503
|
0.302 ng/mL
Standard Deviation 0.214
|
1.17 ng/mL
Standard Deviation 0.799
|
—
|
—
|
—
|
—
|
|
Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1
Predose on Day 5
|
0.0457 ng/mL
Standard Deviation 0.0962
|
1.09 ng/mL
Standard Deviation 1.97
|
1.95 ng/mL
Standard Deviation 2.38
|
—
|
—
|
—
|
—
|
|
Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1
Predose on Day 6
|
0.0423 ng/mL
Standard Deviation 0.0502
|
0.412 ng/mL
Standard Deviation 0.415
|
1.01 ng/mL
Standard Deviation 0.469
|
—
|
—
|
—
|
—
|
|
Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1
Predose on Day 7
|
0.0596 ng/mL
Standard Deviation 0.0905
|
0.336 ng/mL
Standard Deviation 0.383
|
1.48 ng/mL
Standard Deviation 0.936
|
—
|
—
|
—
|
—
|
|
Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1
Predose on Day 8
|
0.0763 ng/mL
Standard Deviation 0.100
|
0.522 ng/mL
Standard Deviation 0.648
|
1.16 ng/mL
Standard Deviation 0.878
|
—
|
—
|
—
|
—
|
|
Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1
Predose on Day 9
|
0.0700 ng/mL
Standard Deviation 0.120
|
0.280 ng/mL
Standard Deviation 0.243
|
1.40 ng/mL
Standard Deviation 1.08
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdosePopulation: PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Tmax. Number analyzed are participants with evaluable data at given time-point.
Outcome measures
| Measure |
Part 1: Placebo
n=13 Participants
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=11 Participants
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=13 Participants
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 in Part 1
Day 1
|
1.00 hour (hr)
Interval 0.48 to 2.0
|
1.00 hour (hr)
Interval 0.5 to 4.0
|
1.00 hour (hr)
Interval 0.5 to 2.0
|
—
|
—
|
—
|
—
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 in Part 1
Day 7
|
1.00 hour (hr)
Interval 0.5 to 2.0
|
1.00 hour (hr)
Interval 0.5 to 1.52
|
0.98 hour (hr)
Interval 0.48 to 1.98
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1: Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: TAK 906 Maleate 5 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: TAK 906 Maleate 25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: TAK 906 Maleate 100 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2: TAK-906 Maleate 25 mg Fed Condition
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: TAK-906 Maleate 25 mg Fasted Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: Metoclopramide 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Placebo
n=12 participants at risk
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=14 participants at risk
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=12 participants at risk
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
n=13 participants at risk
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
n=6 participants at risk
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
n=6 participants at risk
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
n=13 participants at risk
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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
Acute kidney injury
|
8.3%
1/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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=12 participants at risk
TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 5 mg
n=14 participants at risk
TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 25 mg
n=12 participants at risk
TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
|
Part 1: TAK 906 Maleate 100 mg
n=13 participants at risk
TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
|
Part 2: TAK-906 Maleate 25 mg Fed Condition
n=6 participants at risk
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.
|
Part 2: TAK-906 Maleate 25 mg Fasted Condition
n=6 participants at risk
TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
|
Part 2: Metoclopramide 10 mg
n=13 participants at risk
Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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 spasms
|
0.00%
0/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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
|
8.3%
1/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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
|
8.3%
1/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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
|
8.3%
1/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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%
0/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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%
0/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
2/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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
Asthenia
|
0.00%
0/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Conjunctivitis
|
8.3%
1/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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
Liver function test increased
|
0.00%
0/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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
Type 2 diabetes mellitus
|
0.00%
0/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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
|
8.3%
1/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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%
0/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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
Tremor
|
0.00%
0/12 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and 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 The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER