Trial Outcomes & Findings for Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies (NCT NCT03166215)
NCT ID: NCT03166215
Last Updated: 2021-01-07
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 (eg, 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
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
From first dose up to 30 days post last dose (approximately up to 120 days)
Results posted on
2021-01-07
Participant Flow
Participants took part in the study at 10 investigative sites in the United States from 17 August 2017 to 19 September 2018.
Participants with a diagnosis of developmental and/or epileptic encephalopathies were enrolled to receive TAK-935 or placebo in Part 1 \[Double Blind Treatment Period (TP)\] and Part 2 (Open Label TP).
Participant milestones
| Measure |
Part 1: Placebo
TAK-935 matching-placebo tablets, orally or through gastrostomy tube (G-tube)/percutaneous endoscopic gastrostomy (PEG) tube, twice daily (BID) from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Part 1 (Double-blind TP: Days 1 - 30)
STARTED
|
4
|
14
|
0
|
|
Part 1 (Double-blind TP: Days 1 - 30)
COMPLETED
|
4
|
12
|
0
|
|
Part 1 (Double-blind TP: Days 1 - 30)
NOT COMPLETED
|
0
|
2
|
0
|
|
Part 2 (Open-Label TP: Days 31 - 85)
STARTED
|
0
|
0
|
16
|
|
Part 2 (Open-Label TP: Days 31 - 85)
COMPLETED
|
0
|
0
|
14
|
|
Part 2 (Open-Label TP: Days 31 - 85)
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Part 1: Placebo
TAK-935 matching-placebo tablets, orally or through gastrostomy tube (G-tube)/percutaneous endoscopic gastrostomy (PEG) tube, twice daily (BID) from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Part 1 (Double-blind TP: Days 1 - 30)
Adverse Event
|
0
|
2
|
0
|
|
Part 2 (Open-Label TP: Days 31 - 85)
Adverse Event
|
0
|
0
|
2
|
Baseline Characteristics
Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies
Baseline characteristics by cohort
| Measure |
Part 1: Placebo
n=4 Participants
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=14 Participants
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 8.38 • n=5 Participants
|
29.4 years
STANDARD_DEVIATION 7.83 • n=7 Participants
|
29.1 years
STANDARD_DEVIATION 7.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Height
|
170.78 cm
STANDARD_DEVIATION 14.115 • n=5 Participants
|
163.80 cm
STANDARD_DEVIATION 9.746 • n=7 Participants
|
165.35 cm
STANDARD_DEVIATION 10.802 • n=5 Participants
|
|
Weight
|
86.35 kg
STANDARD_DEVIATION 26.651 • n=5 Participants
|
68.57 kg
STANDARD_DEVIATION 21.702 • n=7 Participants
|
72.52 kg
STANDARD_DEVIATION 23.310 • n=5 Participants
|
|
Body Mass Index (BMI)
|
29.08 kg/m^2
STANDARD_DEVIATION 5.688 • n=5 Participants
|
24.61 kg/m^2
STANDARD_DEVIATION 6.639 • n=7 Participants
|
25.61 kg/m^2
STANDARD_DEVIATION 6.562 • n=5 Participants
|
|
Epilepsy Diagnosis
Cerebral Dysgenesis
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Complex Partial Seizure Disorder
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Dravet Syndrome
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Epilepsy
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Epileptic Encephalopathy
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Frontal Lobe Epilepsy
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Hypothalamic Hamartoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Infantile Spasms
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Infantile Spasms That Went On To Lennox-Gastaut
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Lennox-Gastaut Syndrome
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Medically Intractable Focal Epilepsy
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Mental Retardation
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Partial Seizures With Secondary Generalization
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Epilepsy With Significant Learning Problem and GDD
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Epilepsy Diagnosis
Tuberous Sclerosis
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose up to 30 days post last dose (approximately up to 120 days)Population: Safety Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug.
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 (eg, 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
Outcome measures
| Measure |
Part 1: Placebo
n=4 Participants
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=14 Participants
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
n=16 Participants
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE), as Reported by the Participants or Participant's Caregivers or Observed by the Investigator, After TAK-935 Treatment
|
100 percentage of participants
|
71.4 percentage of participants
|
68.8 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dosePopulation: Pharmacokinetic (PK) Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or metabolite of TAK-935 (M-I) plasma concentration.
Outcome measures
| Measure |
Part 1: Placebo
n=13 Participants
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=16 Participants
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
n=13 Participants
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Drug Clearance (CL) and Intercompartmental Clearance (Q) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration
CL
|
259.4 L/hr
Standard Deviation 148.1
|
195.8 L/hr
Standard Deviation 116.3
|
190 L/hr
Standard Deviation 108.5
|
|
Drug Clearance (CL) and Intercompartmental Clearance (Q) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration
Q
|
100.6 L/hr
Standard Deviation 22.24
|
70.99 L/hr
Standard Deviation 14.6
|
57.77 L/hr
Standard Deviation 11.36
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dosePopulation: PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration.
Outcome measures
| Measure |
Part 1: Placebo
n=13 Participants
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=16 Participants
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
n=13 Participants
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Central Compartment (Vc) and Peripheral Compartment (Vp) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration
Vc
|
56.59 L
Standard Deviation 22.72
|
60.51 L
Standard Deviation 23.79
|
62 L
Standard Deviation 26.54
|
|
Apparent Volume of Distribution (Vz/F) of Central Compartment (Vc) and Peripheral Compartment (Vp) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration
Vp
|
677.1 L
Standard Deviation 296.2
|
474.3 L
Standard Deviation 201.9
|
352.9 L
Standard Deviation 138.7
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dosePopulation: PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration.
Outcome measures
| Measure |
Part 1: Placebo
n=13 Participants
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=16 Participants
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
n=13 Participants
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Absorption Rate Constant (Ka) for TAK-935
|
2.13 1/hr
Standard Deviation 0
|
2.13 1/hr
Standard Deviation 0
|
2.13 1/hr
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dosePopulation: PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration.
Outcome measures
| Measure |
Part 1: Placebo
n=13 Participants
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=16 Participants
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
n=13 Participants
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Cmax,ss: Maximum Observed Plasma Concentration for TAK-935 at Steady State
|
269.6 ng/mL
Standard Deviation 159.6
|
639.8 ng/mL
Standard Deviation 354.8
|
975.3 ng/mL
Standard Deviation 411.5
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dosePopulation: PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration.
Outcome measures
| Measure |
Part 1: Placebo
n=13 Participants
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=16 Participants
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
n=13 Participants
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
AUC0-tau,ss: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for TAK-935 at Steady State
|
562.5 ng*hr/mL
Standard Deviation 406.8
|
1437 ng*hr/mL
Standard Deviation 909
|
2188 ng*hr/mL
Standard Deviation 1357
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dosePopulation: PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration.
Outcome measures
| Measure |
Part 1: Placebo
n=13 Participants
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=16 Participants
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
n=13 Participants
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Cav,ss: Average Plasma Concentration During a Dosing Interval at Steady State for TAK-935
|
46.9 ng/mL
Standard Deviation 33.9
|
119.8 ng/mL
Standard Deviation 75.75
|
182.3 ng/mL
Standard Deviation 113.1
|
SECONDARY outcome
Timeframe: Days 1, 11, 21; Days 31, 41 and 85 pre-dosePopulation: PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration.
Outcome measures
| Measure |
Part 1: Placebo
n=13 Participants
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=16 Participants
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
n=13 Participants
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Ctrough,ss: Plasma Concentration Immediately Prior to Dosing for TAK-935 at Steady State
|
10.5 ng/mL
Standard Deviation 13.83
|
26 ng/mL
Standard Deviation 29.2
|
30.2 ng/mL
Standard Deviation 29.12
|
SECONDARY outcome
Timeframe: From first dose up to last dose (up to Day 85)Population: Safety Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug. Data reported is the data available for the specific parameter.
Clinical Laboratory parameters: hematology, serum chemistry and urinalysis. Participants with at least 1 markedly abnormal values during treatment period were reported: Erythrocytes: \<0.8xLLN-\>1.5xULN, Hematocrit: \<0.8x LLN \>1.2xULN,Hemoglobin: \<0.8xLLN-\>1.2xULN Leukocytes: \<0.5xLLN, Platelets (10\^9/L): \<75x10\^9/L-\>600x10\^9/L, Prothrombin Ratio: \>1.5xULN, Alanine Aminotransferase: \>3xULN, Albumin:\<25 g/L, Alkaline Phosphatase: \>3xULN,Alpha-1 Acid Glycoprotein: \<47 mg/DL-\>125 mg/DL, Aspartate Aminotransferase:\>3xULN, Bicarbonate:\<8.0 mmol/L, Calcium:\<1.75 mmol/L-\>2.88 mmol/L, Chloride:\<75 mmol/L-\>126 mmol/L, Cholesterol: \>7.72,Creatine Kinase:\>5xULN, Creatinine:\>177 umol/L, Gamma Glutamyl Transferase: \>3xULN, Glucose:\<2.8 mmol/L- \>19.4 mmol/L,HDL Cholesterol: \<1.04 mmol/L-\>1.55 mmol/L, LDL Cholesterol: \<1.30 mmol/L-\>4.14 mmol/L, Potassium:\<3.0 mmol/L-\>6.0 mEq/L, Protein:\<0.8xLLN-\>1.2 x ULN, Sodium: \<130 mmol/L-\>150 mmol/L, Triglycerides: \>2.5xULN, Urea Nitrogen: \>10.7 mmol/L.
Outcome measures
| Measure |
Part 1: Placebo
n=4 Participants
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=14 Participants
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
n=16 Participants
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Clinical Laboratory Evaluations After TAK-935
Alpha-1 Acid Glycoprotein (>125 mg/DL)
|
0 percentage of participants
|
11.1 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Clinical Laboratory Evaluations After TAK-935
Gamma Glutamyl Transferase ( >3 x ULN)
|
0 percentage of participants
|
9.1 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Clinical Laboratory Evaluations After TAK-935
HDL Cholesterol (<1.04 mmol/L)
|
75.0 percentage of participants
|
18.2 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Clinical Laboratory Evaluations After TAK-935
HDL Cholesterol (>1.55 mmol/L)
|
0 percentage of participants
|
27.3 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Clinical Laboratory Evaluations After TAK-935
LDL Cholesterol (>4.14 mmol/L)
|
0 percentage of participants
|
9.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Clinical Laboratory Evaluations After TAK-935
Potassium (>6.0 mmol/L)
|
0 percentage of participants
|
9.1 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 30 days post last dose (approximately up 120 days)Population: Safety Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug. Data reported is the data available for the specific parameter.
Vital signs included heart rate, blood pressure and body temperature. markedly abnormal values during treatment period were categorized as: heart rate 1,3 and 5 min standing (beats/min) \<50-\>120, systolic blood pressure 1,3 and 5 min standing (mmHg) \<85-\>180, diastolic blood pressure 1,3 and 5 min standing (mmHg) \<50-\>110 and body temperature (degree centigrade) \<35.6- \>37.7. Only categories with values have been reported.
Outcome measures
| Measure |
Part 1: Placebo
n=4 Participants
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=14 Participants
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
n=16 Participants
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Vital Signs After TAK-935
Diastolic Blood Pressure 3 min Standing (<50 mmHg)
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Vital Signs After TAK-935
Diastolic Blood Pressure 5 min Sitting (<50 mmHg)
|
0 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Vital Signs After TAK-935
Diastolic Blood Pressure 5 min Supine (<50 mmHg)
|
25.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Vital Signs After TAK-935
Heart Rate 1 min Standing (>120 beats/min)
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Vital Signs After TAK-935
Heart Rate 5 min Sitting (<50 beats/min)
|
50.0 percentage of participants
|
0 percentage of participants
|
6.3 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Vital Signs After TAK-935
Heart Rate 5 min Supine (<50 beats/min)
|
25.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Vital Signs After TAK-935
Systolic Blood Pressure 5 min Sitting (<85 mmHg)
|
0 percentage of participants
|
7.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Vital Signs After TAK-935
Temperature (<35.6 C)
|
25.0 percentage of participants
|
7.7 percentage of participants
|
18.8 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to last dose (up to Day 85)Population: Safety Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug. Data reported is the data available for the specific parameter.
A 12-lead ECG was performed. Markedly abnormal values during treatment period were categorized as: ECG ventricular rate \<50-\>120, PR Interval, (msec) \<=80-\>=200, QRS Duration, (msec) \<=80-\>=180, QT Interval, (msec) \<=50-\>=460, QTcF Interval, (msec) \<=50-\>=500 OR \>=30 change from baseline and \>=450 milliseconds, RR interval \<600-\>=1440.
Outcome measures
| Measure |
Part 1: Placebo
n=4 Participants
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=14 Participants
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
n=16 Participants
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Electrocardiogram (ECG) Parameters After TAK-935
ECG Ventricular Rate (<50 beats/min)
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Electrocardiogram (ECG) Parameters After TAK-935
QRS Duration (<=80 msec)
|
0 percentage of participants
|
12.5 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With at Least 1 Markedly Abnormal Value for Electrocardiogram (ECG) Parameters After TAK-935
RR Interval (<=600 msec)
|
0 percentage of participants
|
0 percentage of participants
|
13.3 percentage of participants
|
Adverse Events
Part 1: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1: TAK-935
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 2: TAK-935
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Placebo
n=4 participants at risk
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=14 participants at risk
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
n=16 participants at risk
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Nervous system disorders
Seizure Cluster
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
12.5%
2/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
Other adverse events
| Measure |
Part 1: Placebo
n=4 participants at risk
TAK-935 matching-placebo tablets, orally or through G-tube/PEG tube, BID from Days 1 to 30 in dose titration period.
|
Part 1: TAK-935
n=14 participants at risk
TAK-935 100 mg, tablet, orally or through G-tube/PEG tube, BID from Days 1 to 10 followed by TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 11 to 20 followed by TAK-935 100 mg tablets x3, orally or through G-tube/PEG tube, BID from Days 21 to 30 in dose titration period. The dose of TAK-935 was escalated or de-escalated during Part 1 as per investigator's discretion.
|
Part 2: TAK-935
n=16 participants at risk
TAK-935 100 mg tablets x2, orally or through G-tube/PEG tube, BID from Days 31 to 40 followed by TAK-935 100 mg tablets x1, x2 or x3, orally or through G-tube/PEG tube, BID from Days 31 to Day 85 as per investigator's discretion in the maintenance period. At the end of Part 2, the dose of TAK-935 was de-escalated until discontinuation.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
14.3%
2/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
18.8%
3/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Psychiatric disorders
Communication disorder
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Psychiatric disorders
Irritability
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Psychiatric disorders
Listless
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Psychiatric disorders
Sleep talking
|
25.0%
1/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Psychiatric disorders
Tic
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
21.4%
3/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
14.3%
2/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
14.3%
2/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
12.5%
2/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
18.8%
3/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Nervous system disorders
Repetitive speech
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Nervous system disorders
Sedation
|
25.0%
1/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Nervous system disorders
Tonic convulsion
|
25.0%
1/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
25.0%
1/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Renal and urinary disorders
Urinary incontinence
|
25.0%
1/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
General disorders
Fatigue
|
25.0%
1/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
14.3%
2/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
General disorders
Asthenia
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Investigations
Weight increased
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
12.5%
2/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
6.2%
1/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Injury, poisoning and procedural complications
Human bite
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/4 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
7.1%
1/14 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
0.00%
0/16 • From first dose up to 30 days post last dose (approximately up to 120 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER