Trial · NCT04091438

A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia

NCT04091438, Phase 1, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2023-09-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia. Trials, record NCT04091438. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04091438

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
NCT number: NCT04091438
Status: Completed
Phases: Phase 1
Enrollment: 28 participants, actual
Lead sponsor: Millennium Pharmaceuticals, Inc.
Conditions: Idiopathic Hypersomnia
Interventions: TAK-925, TAK-925 Placebo
First posted: 2019-09-16
Last updated: 2023-09-26
Results first posted: 2023-09-26

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)	Study Day 1 up to Study Day 11
Primary	Percentage of Participants With Markedly Abnormal Criteria for Clinical Safety Laboratory Tests	Study Day 1 up to Study Day 11
Primary	Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements	From Predose up to Study Day 4
Primary	Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters	Study Day 1 up to Study Day 4
Secondary	Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925	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
Secondary	AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925	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
Secondary	AUC Last: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-925	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

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)	Study Day 1 up to Study Day 11	The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.	percentage of participants	NUMBER
PRIMARY	Percentage of Participants With Markedly Abnormal Criteria for Clinical Safety Laboratory Tests	Study Day 1 up to Study Day 11	The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.	percentage of participants	NUMBER
PRIMARY	Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements	From Predose up to Study Day 4	The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.	percentage of participants	NUMBER
PRIMARY	Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters	Study Day 1 up to Study Day 4	The safety analysis set included all participants who were randomized and received at least 1 dose of the study drug.	percentage of participants	NUMBER
SECONDARY	Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925	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	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.	nanogram per milliliter (ng/mL)	GEOMETRIC_MEAN
SECONDARY	AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925	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	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.	nanogramhour per milliliter (ngh/mL)	GEOMETRIC_MEAN
SECONDARY	AUC Last: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-925	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	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.	ng*h/mL	GEOMETRIC_MEAN

Source ClinicalTrials.gov

Results by group41

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)	Placebo		14.8	percentage of participants
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)	TAK-925 112 mg		40.0	percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Clinical Safety Laboratory Tests	Placebo		3.7	percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Clinical Safety Laboratory Tests	TAK 925 112 mg		0	percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements	Placebo	Systolic Blood Pressure: less than (<) 90 millimeter of mercury (mmHg)	14.8	percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements	TAK-925 112 mg	Systolic Blood Pressure: less than (<) 90 millimeter of mercury (mmHg)	12.0	percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements	Placebo	Systolic Blood Pressure: greater than or equal to (>=) 160mmHg	0	percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements	TAK-925 112 mg	Systolic Blood Pressure: greater than or equal to (>=) 160mmHg	0	percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements	Placebo	Systolic Blood Pressure: Change from predose greater than (>) 20 mmHg	11.1	percentage of participants
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements	TAK-925 112 mg	Systolic Blood Pressure: Change from predose greater than (>) 20 mmHg	0	percentage of participants

1 to 10 of 41Source ClinicalTrials.gov

See all 41 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period 1 (1 Day)	STARTED	Sequence 1: TAK 925 112 mg + Placebo	14
Treatment Period 1 (1 Day)	STARTED	Sequence 2: Placebo + TAK-925 112 mg	14
Treatment Period 1 (1 Day)	Treated	Sequence 1: TAK 925 112 mg + Placebo	13
Treatment Period 1 (1 Day)	Treated	Sequence 2: Placebo + TAK-925 112 mg	14
Treatment Period 1 (1 Day)	COMPLETED	Sequence 1: TAK 925 112 mg + Placebo	13
Treatment Period 1 (1 Day)	COMPLETED	Sequence 2: Placebo + TAK-925 112 mg	14
Treatment Period 1 (1 Day)	NOT COMPLETED	Sequence 1: TAK 925 112 mg + Placebo	1
Treatment Period 1 (1 Day)	NOT COMPLETED	Sequence 2: Placebo + TAK-925 112 mg	0
Washout Period (1 Day)	STARTED	Sequence 1: TAK 925 112 mg + Placebo	13
Washout Period (1 Day)	STARTED	Sequence 2: Placebo + TAK-925 112 mg	14

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	Placebo	2	27
other	Headache	Nervous system disorders	TAK-925 112 mg	1	25
other	Dizziness	Nervous system disorders	Placebo	0	27
other	Dizziness	Nervous system disorders	TAK-925 112 mg	2	25
other	Pollakiuria	Renal and urinary disorders	Placebo	0	27
other	Pollakiuria	Renal and urinary disorders	TAK-925 112 mg	3	25
other	Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Placebo	0	27
other	Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	TAK-925 112 mg	2	25

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	27
Total, all-cause mortality	TAK-925 112 mg	0	25
Total, other adverse events	Placebo	2	27
Total, other adverse events	TAK-925 112 mg	5	25
Total, serious adverse events	Placebo	0	27
Total, serious adverse events	TAK-925 112 mg	0	25

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36883238	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
TAK-925 112 mg vs Placebo: deaths from any cause	Trial comparisons
TAK-925 112 mg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04091438

GET https://conductscience.org/api/trials/v1/NCT04091438/results?page=2

API reference For AI assistants