Trial Outcomes & Findings for A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia (NCT NCT04091438)
NCT ID: NCT04091438
Last Updated: 2023-09-26
Results Overview
COMPLETED
PHASE1
28 participants
Study Day 1 up to Study Day 11
2023-09-26
Participant Flow
Participants took part in the study at 13 investigative sites in the United States and Japan from 26 January 2020 to 23 November 2020.
Participants with idiopathic hypersomnia (IH) were enrolled in one of the two treatment sequences of this 2-period crossover study to receive TAK-925 112 milligram (mg) infusion or placebo.
Participant milestones
| Measure |
Sequence 1: TAK 925 112 mg + Placebo
TAK-925 112 mg, infusion, intravenously, once on Day 1 (Study Day 1) of Treatment Period 1, followed by 24 hours washout period, further followed by placebo, infusion, intravenously, once on Day 1 (Study Day 3) of Treatment Period 2.
|
Sequence 2: Placebo + TAK-925 112 mg
Placebo, infusion, intravenously, once on Day 1 (Study Day 1) of Treatment Period 1, followed by 24 hours washout period, further followed by TAK-925 112 mg, intravenously, once on Day 1 (Study Day 3) of Treatment Period 2.
|
|---|---|---|
|
Treatment Period 1 (1 Day)
STARTED
|
14
|
14
|
|
Treatment Period 1 (1 Day)
Treated
|
13
|
14
|
|
Treatment Period 1 (1 Day)
COMPLETED
|
13
|
14
|
|
Treatment Period 1 (1 Day)
NOT COMPLETED
|
1
|
0
|
|
Washout Period (1 Day)
STARTED
|
13
|
14
|
|
Washout Period (1 Day)
COMPLETED
|
13
|
12
|
|
Washout Period (1 Day)
NOT COMPLETED
|
0
|
2
|
|
Treatment Period 2 (1 Day)
STARTED
|
13
|
12
|
|
Treatment Period 2 (1 Day)
COMPLETED
|
13
|
12
|
|
Treatment Period 2 (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: TAK 925 112 mg + Placebo
TAK-925 112 mg, infusion, intravenously, once on Day 1 (Study Day 1) of Treatment Period 1, followed by 24 hours washout period, further followed by placebo, infusion, intravenously, once on Day 1 (Study Day 3) of Treatment Period 2.
|
Sequence 2: Placebo + TAK-925 112 mg
Placebo, infusion, intravenously, once on Day 1 (Study Day 1) of Treatment Period 1, followed by 24 hours washout period, further followed by TAK-925 112 mg, intravenously, once on Day 1 (Study Day 3) of Treatment Period 2.
|
|---|---|---|
|
Treatment Period 1 (1 Day)
Other
|
1
|
0
|
|
Washout Period (1 Day)
Protocol deviation
|
0
|
1
|
|
Washout Period (1 Day)
Other
|
0
|
1
|
Baseline Characteristics
A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
Baseline characteristics by cohort
| Measure |
Sequence 1: TAK 925 112 mg + Placebo
n=13 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 (Study Day 1) of Treatment Period 1, followed by 24 hours washout period, further followed by placebo, infusion, intravenously, once on Day 1 (Study Day 3) of Treatment Period 2.
|
Sequence 2: Placebo + TAK-925 112 mg
n=14 Participants
Placebo, infusion, intravenously, once on Day 1 (Study Day 1) of Treatment Period 1, followed by 24 hours washout period, further followed by TAK-925 112 mg, intravenously, once on Day 1 (Study Day 3) of Treatment Period 2.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.0 years
STANDARD_DEVIATION 9.97 • n=5 Participants
|
31.5 years
STANDARD_DEVIATION 7.91 • n=7 Participants
|
31.7 years
STANDARD_DEVIATION 8.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States of America
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Height
|
165.18 centimeter (cm)
STANDARD_DEVIATION 8.077 • n=5 Participants
|
170.10 centimeter (cm)
STANDARD_DEVIATION 9.924 • n=7 Participants
|
167.73 centimeter (cm)
STANDARD_DEVIATION 9.253 • n=5 Participants
|
|
Weight
|
64.33 kilogram (kg)
STANDARD_DEVIATION 11.501 • n=5 Participants
|
78.88 kilogram (kg)
STANDARD_DEVIATION 16.067 • n=7 Participants
|
71.87 kilogram (kg)
STANDARD_DEVIATION 15.652 • n=5 Participants
|
|
Body Mass Index (BMI)
|
23.47 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.336 • n=5 Participants
|
27.02 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.597 • n=7 Participants
|
25.31 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.857 • n=5 Participants
|
PRIMARY outcome
Timeframe: Study Day 1 up to Study Day 11Population: The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.
Outcome measures
| Measure |
Placebo
n=27 Participants
Placebo, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
TAK-925 112 mg
n=25 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
|---|---|---|
|
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
|
14.8 percentage of participants
|
40.0 percentage of participants
|
PRIMARY outcome
Timeframe: Study Day 1 up to Study Day 11Population: The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.
Outcome measures
| Measure |
Placebo
n=27 Participants
Placebo, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
TAK-925 112 mg
n=25 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
|---|---|---|
|
Percentage of Participants With Markedly Abnormal Criteria for Clinical Safety Laboratory Tests
|
3.7 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: From Predose up to Study Day 4Population: The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.
Outcome measures
| Measure |
Placebo
n=27 Participants
Placebo, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
TAK-925 112 mg
n=25 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
|---|---|---|
|
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements
Diastolic Blood Pressure: <50 mmHg
|
0 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements
Diastolic Blood Pressure: >=100 mmHg
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements
Heart Rate: >115 bpm
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements
Systolic Blood Pressure: less than (<) 90 millimeter of mercury (mmHg)
|
14.8 percentage of participants
|
12.0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements
Systolic Blood Pressure: greater than or equal to (>=) 160mmHg
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements
Systolic Blood Pressure: Change from predose greater than (>) 20 mmHg
|
11.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements
Diastolic Blood Pressure: Change from predose >20 mmHg
|
14.8 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements
Heart Rate: <40 beats per minute (bpm)
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Study Day 1 up to Study Day 4Population: The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.
Outcome measures
| Measure |
Placebo
n=27 Participants
Placebo, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
TAK-925 112 mg
n=25 Participants
TAK-925 112 mg, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
|---|---|---|
|
Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters
PR Interval, Aggregate: <=80 millisecond (msec)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters
PR Interval, Aggregate: >=200 msec
|
3.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters
Heart Rate: <40 bpm
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters
QRS Duration, Aggregate: <= 80 msec
|
11.1 percentage of participants
|
12.0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters
QRS Duration, Aggregate: >=180 msec
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters
QTcF Interval, Aggregate: <=300 msec
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters
QTcF Interval, Aggregate: >500 msec
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters
QTcF Interval, Aggregate: >=30 change from baseline and >450 msec
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters
Heart Rate: >115 bpm
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusionPopulation: The Pharmacokinetic (PK) analysis set included participants who receive at least 1 dose of study drug and who had at least 1 measurable plasma concentration of TAK-925 (or its metabolites). Here "overall number of participants" analyzed are those who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
|---|---|---|
|
Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925
|
222.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31.3
|
—
|
SECONDARY outcome
Timeframe: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusionPopulation: The PK analysis set included participants who receive at least 1 dose of study drug and who had at least 1 measurable plasma concentration of TAK-925 (or its metabolites). Here "overall number of participants" analyzed are those who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925
|
2253 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 22.5
|
—
|
SECONDARY outcome
Timeframe: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusionPopulation: The PK analysis set included participants who receive at least 1 dose of study drug and who had at least 1 measurable plasma concentration of TAK-925 (or its metabolites). Here "overall number of participants" analyzed are those who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
TAK-925 112 mg
TAK-925 112 mg, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
|---|---|---|
|
AUC Last: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-925
|
2265 ng*h/mL
Geometric Coefficient of Variation 22.3
|
—
|
Adverse Events
Placebo
TAK-925 112 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=27 participants at risk
Placebo, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
TAK-925 112 mg
n=25 participants at risk
TAK-925 112 mg, infusion, intravenously, once on Day 1 (Study Day 1 or Study Day 3) of Treatment Period 1 or 2.
|
|---|---|---|
|
Nervous system disorders
Headache
|
7.4%
2/27 • TEAEs were adverse events that started after the start of the first infusion of study treatment (Study Day 1) up to Study Day 11
At each visit the investigator had to document any occurrence of adverse events, including clinically significant abnormal clinical laboratory, vital sign or ECG values. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
1/25 • TEAEs were adverse events that started after the start of the first infusion of study treatment (Study Day 1) up to Study Day 11
At each visit the investigator had to document any occurrence of adverse events, including clinically significant abnormal clinical laboratory, vital sign or ECG values. 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%
0/27 • TEAEs were adverse events that started after the start of the first infusion of study treatment (Study Day 1) up to Study Day 11
At each visit the investigator had to document any occurrence of adverse events, including clinically significant abnormal clinical laboratory, vital sign or ECG values. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.0%
2/25 • TEAEs were adverse events that started after the start of the first infusion of study treatment (Study Day 1) up to Study Day 11
At each visit the investigator had to document any occurrence of adverse events, including clinically significant abnormal clinical laboratory, vital sign or ECG values. 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
Pollakiuria
|
0.00%
0/27 • TEAEs were adverse events that started after the start of the first infusion of study treatment (Study Day 1) up to Study Day 11
At each visit the investigator had to document any occurrence of adverse events, including clinically significant abnormal clinical laboratory, vital sign or ECG values. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.0%
3/25 • TEAEs were adverse events that started after the start of the first infusion of study treatment (Study Day 1) up to Study Day 11
At each visit the investigator had to document any occurrence of adverse events, including clinically significant abnormal clinical laboratory, vital sign or ECG values. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/27 • TEAEs were adverse events that started after the start of the first infusion of study treatment (Study Day 1) up to Study Day 11
At each visit the investigator had to document any occurrence of adverse events, including clinically significant abnormal clinical laboratory, vital sign or ECG values. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.0%
2/25 • TEAEs were adverse events that started after the start of the first infusion of study treatment (Study Day 1) up to Study Day 11
At each visit the investigator had to document any occurrence of adverse events, including clinically significant abnormal clinical laboratory, vital sign or ECG values. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER