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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

Study Day 1 up to Study Day 11

Results posted on

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

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

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

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 11

Population: The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.

Outcome measures

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 11

Population: The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.

Outcome measures

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 4

Population: The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.

Outcome measures

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 4

Population: The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.

Outcome measures

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 infusion

Population: 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

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 infusion

Population: 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

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 infusion

Population: 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

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

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

TAK-925 112 mg

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Study Director

Takeda

Phone: +1-877-825-3327

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