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A Study of TAK-951 in Healthy Adults

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-951 in Healthy Subjects Following Intravenous Administration

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04486950
Enrollment
32
Registered
2020-07-27
Start date
2020-07-07
Completion date
2021-05-27
Last updated
2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Drug Therapy

Brief summary

It is hoped that a medicine called TAK-951 will eventually be used to treat nausea and vomiting. Before then, the sponsor needs to understand how the body processes TAK-951 in healthy adults. The main aims of this study are as follows: * To check for side effects from TAK-951 when given at a slow and fast infusion rate. * To learn how much TAK-951 participants can receive without getting side effects from it. Participants will receive a single infusion of either TAK-951 or placebo. In this study, a placebo looks like TAK-951 but does not have any medicine in it. Participants will receive either a low dose or high dose of TAK-951. The infusion will take from 1-3 hours. Participants will stay in the study clinic for about 4 days to receive the study medicine (TAK-951 or placebo) and check for side effects. They will have follow-up visits at the clinic about 2 weeks and 4 weeks after treatment.

Detailed description

The drug being tested in this study is called TAK-951. The study will evaluate the safety, tolerability and PK of TAK-951 in healthy participants. The study will enroll approximately 40 healthy participants. Each cohort will have 8 participants to be randomized and a minimum of 3 cohorts will be evaluated. Participants will be randomly assigned (by chance, like flipping a coin) to receive TAK-951 or placebo in a 6:2 ratio in one of the following 3 cohorts, which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes * Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes * Cohort 3: TAK-951 1 mg Infusion over 120 Minutes Sentinel dosing will be done in first 2 participants in each cohort. The dosing in rest of the cohort will done if there are no significant safety or tolerability concerns. Additional 2 cohorts, each cohort with 8 participants may be added in study to evaluate additional intravenous dosing regimen after clinical data analysis of first 3 cohorts. Dosing of the subsequent cohort will be based on the analysis of the previous cohort's data. This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 57 days. All participants will return to clinic after 14 and 28 days after the last visit to the clinic for a follow-up assessment.

Interventions

DRUGTAK-951

TAK-951 intravenous infusion.

DRUGTAK-951 Placebo

TAK-951 placebo-matching intravenous infusion.

Sponsors

Takeda
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

1. Continuous non-smoker who has not used nicotine- and tobacco-containing products and/or cannabis products for at least 3 months prior to dosing and throughout the study. 2. Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 32.0 kilogram per square meter (kg/m\^2) at screening. 3. Female must be of non-childbearing potential.

Exclusion criteria

1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. 2. Drink alcohol in excess of 21 glasses/units per week for males or 14 glasses/units per week for females, with one unit equal to (=) 150 milliliter (mL) of wine or 360 mL of beer or 45 mL of 45 percent (%) alcohol. 3. Have any tattoos, scars or skin issue at planned IV infusion site which could interfere with dosing. 4. History or presence of: * Three (3) or more incidences of vasovagal syncope within the last 5 years prior to screening. * Family history of unexplained sudden death or channelopathy. * Brugada syndrome (that is, right bundle branch block (RBBB) pattern with ST-elevation in leads V1-V3). * Cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, sick sinus syndrome, pulmonary congestion, symptomatic or significant cardiac arrhythmia, second-degree AV block type 2, third-degree AV block, prolonged corrected QT interval by Fredericia (QTcF) interval, hypokalemia, hypomagnesemia, or conduction abnormalities; * Risk factors for Torsade de Pointes (example, heart failure, cardiomyopathy, or family history of Long QT Syndrome); * Any clinically significant ECG findings or medical history including: long or short QT interval with QTcF (over 450 msec or less than 360 msec), bifascicular block or QRS \>=120 msec or PR interval greater than (\>) 200 msec at screening or Day -1 pre-Hour 0. * Documented history of sinoatrial block or sinus pause \>=3 seconds. 5. Semi-recumbent blood pressure (average of duplicate) is less than 90/60 millimeter of mercury (mmHg) or greater than 140/90 mmHg at screening. 6. Has an average semi-recumbent heart rate \<60 or \>100 beats per minute (bpm) (at screening, at Day -1 pre-Hour 0, or at pre-dose Day 1); athletic participants with an average semi-recumbent heart rate \<60 bpm can be enrolled only with medical monitor approval. If participant has heart rate \<60 bpm Investigator should obtain medical approval from Sponsor. 7. Has orthostatic hypotension defined as a decrease in systolic blood pressure \>=20 mmHg or a decrease in diastolic blood pressure \>=10 mmHg after 2 minutes of standing when compared with blood pressure from the semi-recumbent position at screening and at Day -1 pre-Hour 0. The semi-recumbent blood pressure will be an average of duplicate measurements. 8. Has postural orthostatic tachycardia, defined as an increase of 30 bpm or heart rate \>120 bpm after standing for 2 minutes. 9. Positive urine drug or alcohol results at screening or check-in. 10. Positive urine cotinine at screening or check-in. 11. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV). 12. Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study. Thyroid hormone replacement medication may be permitted if the participant has been on same stable dose for the last 3 months prior to study drug administration. After dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the Investigator or designee. Hormone replacement therapy will also be allowed. 13. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to dosing and throughout the study. 14. Donation of blood or significant blood loss within 56 days prior to dosing. 15. Plasma donation within 7 days prior to dosing. 16. Has positive results for Coronavirus disease 2019 (COVID-19) testing at screening or check-in.

Design outcomes

Primary

MeasureTime frame
Number of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)Baseline up to Day 29
Number of Participants With Clinically Significant Change From Baseline in Vital Sign ValuesBaseline up to Day 2
Number of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) ValuesBaseline up to Day 2
Number of Participants With Clinically Significant Change From Baseline in Laboratory ValuesBaseline up to Day 2
Number of Participants With Clinically Significant Change From Baseline in Physical Examination ValuesBaseline up to Day 29

Secondary

MeasureTime frameDescription
λz: Terminal Disposition Phase Rate Constant for TAK-951Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose—
Number of Participants With Positive Anti-drug Antibodies (ADA) in SerumBaseline up to Day 29ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-951Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose—
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose—
Ceoi: Plasma Concentration at the End of Infusion for TAK-951Day 1: at the end of infusion (at 30 hours post-infusion)—
T1/2z: Terminal Disposition Phase Half-life for TAK-951Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose—

Countries

United States

Participant flow

Recruitment details

Participants took part in the study at 1 investigative site in the United States from 07 July 2020 to 27 May 2021.

Pre-assignment details

Healthy participants were randomized and treated sequentially in Cohorts: 1, 2, 3 and 4 to receive intravenous infusion of TAK-951 20 microgram (mcg), TAK-951 1.0 milligram (mg) or TAK-951 matching placebo (normal saline).

Participants by arm

ArmCount
Cohorts 1 to 2, Treatment P1: Placebo Pooled
TAK-951 placebo-matching (0.2 ml normal saline), infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
4
Cohort 3, Treatment P2: Placebo
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
2
Cohort 4, Treatment P3: Placebo
TAK-951 placebo-matching (1 ml normal saline), infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
2
Cohort 1, Treatment A: TAK-951 20 mcg
TAK-951 20 mcg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
6
Cohort 2, Treatment B: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 60 minutes in fasted condition once on Day 1 in healthy participants.
6
Cohort 3, Treatment C: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 120 minutes in fasted condition once on Day 1 in healthy participants.
6
Cohort 4, Treatment D: TAK-951 1.0 mg
TAK-951 1.0 mg, infusion, intravenously over 180 minutes in fasted condition once on Day 1 in healthy participants.
6
Total32

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006
Overall StudyLost to Follow-up0000010

Baseline characteristics

CharacteristicTotalCohort 3, Treatment P2: PlaceboCohort 4, Treatment P3: PlaceboCohort 1, Treatment A: TAK-951 20 mcgCohort 2, Treatment B: TAK-951 1.0 mgCohorts 1 to 2, Treatment P1: Placebo PooledCohort 3, Treatment C: TAK-951 1.0 mgCohort 4, Treatment D: TAK-951 1.0 mg
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
32 Participants2 Participants2 Participants6 Participants6 Participants4 Participants6 Participants6 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
29 Participants2 Participants2 Participants6 Participants6 Participants4 Participants5 Participants4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
5 Participants1 Participants0 Participants1 Participants0 Participants1 Participants2 Participants0 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
25 Participants1 Participants2 Participants4 Participants5 Participants3 Participants4 Participants6 Participants
Region of Enrollment
United States
32 Participants2 Participants2 Participants6 Participants6 Participants4 Participants6 Participants6 Participants
Sex: Female, Male
Female
3 Participants0 Participants0 Participants2 Participants0 Participants0 Participants1 Participants0 Participants
Sex: Female, Male
Male
29 Participants2 Participants2 Participants4 Participants6 Participants4 Participants5 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
deaths
Total, all-cause mortality
0 / 40 / 20 / 20 / 60 / 60 / 60 / 6
other
Total, other adverse events
1 / 40 / 21 / 23 / 61 / 63 / 61 / 6
serious
Total, serious adverse events
0 / 40 / 20 / 20 / 60 / 60 / 60 / 6

Outcome results

Primary

Number of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)

Time frame: Baseline up to Day 29

Population: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohorts 1 to 2, Treatment P1: Placebo PooledNumber of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)1 Participants
Cohort 3, Treatment P2: PlaceboNumber of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)0 Participants
Cohort 4, Treatment P3: PlaceboNumber of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)1 Participants
Cohort 1, Treatment A: TAK-951 20 mcgNumber of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)3 Participants
Cohort 2, Treatment B: TAK-951 1.0 mgNumber of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)1 Participants
Cohort 3, Treatment C: TAK-951 1.0 mgNumber of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)3 Participants
Cohort 4, Treatment D: TAK-951 1.0 mgNumber of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)1 Participants
Primary

Number of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values

Time frame: Baseline up to Day 2

Population: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohorts 1 to 2, Treatment P1: Placebo PooledNumber of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values0 Participants
Cohort 3, Treatment P2: PlaceboNumber of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values0 Participants
Cohort 4, Treatment P3: PlaceboNumber of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values0 Participants
Cohort 1, Treatment A: TAK-951 20 mcgNumber of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values0 Participants
Cohort 2, Treatment B: TAK-951 1.0 mgNumber of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values0 Participants
Cohort 3, Treatment C: TAK-951 1.0 mgNumber of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values0 Participants
Cohort 4, Treatment D: TAK-951 1.0 mgNumber of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values0 Participants
Primary

Number of Participants With Clinically Significant Change From Baseline in Laboratory Values

Time frame: Baseline up to Day 2

Population: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohorts 1 to 2, Treatment P1: Placebo PooledNumber of Participants With Clinically Significant Change From Baseline in Laboratory Values0 Participants
Cohort 3, Treatment P2: PlaceboNumber of Participants With Clinically Significant Change From Baseline in Laboratory Values0 Participants
Cohort 4, Treatment P3: PlaceboNumber of Participants With Clinically Significant Change From Baseline in Laboratory Values0 Participants
Cohort 1, Treatment A: TAK-951 20 mcgNumber of Participants With Clinically Significant Change From Baseline in Laboratory Values0 Participants
Cohort 2, Treatment B: TAK-951 1.0 mgNumber of Participants With Clinically Significant Change From Baseline in Laboratory Values0 Participants
Cohort 3, Treatment C: TAK-951 1.0 mgNumber of Participants With Clinically Significant Change From Baseline in Laboratory Values0 Participants
Cohort 4, Treatment D: TAK-951 1.0 mgNumber of Participants With Clinically Significant Change From Baseline in Laboratory Values0 Participants
Primary

Number of Participants With Clinically Significant Change From Baseline in Physical Examination Values

Time frame: Baseline up to Day 29

Population: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohorts 1 to 2, Treatment P1: Placebo PooledNumber of Participants With Clinically Significant Change From Baseline in Physical Examination Values0 Participants
Cohort 3, Treatment P2: PlaceboNumber of Participants With Clinically Significant Change From Baseline in Physical Examination Values0 Participants
Cohort 4, Treatment P3: PlaceboNumber of Participants With Clinically Significant Change From Baseline in Physical Examination Values0 Participants
Cohort 1, Treatment A: TAK-951 20 mcgNumber of Participants With Clinically Significant Change From Baseline in Physical Examination Values0 Participants
Cohort 2, Treatment B: TAK-951 1.0 mgNumber of Participants With Clinically Significant Change From Baseline in Physical Examination Values0 Participants
Cohort 3, Treatment C: TAK-951 1.0 mgNumber of Participants With Clinically Significant Change From Baseline in Physical Examination Values0 Participants
Cohort 4, Treatment D: TAK-951 1.0 mgNumber of Participants With Clinically Significant Change From Baseline in Physical Examination Values0 Participants
Primary

Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values

Time frame: Baseline up to Day 2

Population: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohorts 1 to 2, Treatment P1: Placebo PooledNumber of Participants With Clinically Significant Change From Baseline in Vital Sign Values0 Participants
Cohort 3, Treatment P2: PlaceboNumber of Participants With Clinically Significant Change From Baseline in Vital Sign Values0 Participants
Cohort 4, Treatment P3: PlaceboNumber of Participants With Clinically Significant Change From Baseline in Vital Sign Values0 Participants
Cohort 1, Treatment A: TAK-951 20 mcgNumber of Participants With Clinically Significant Change From Baseline in Vital Sign Values0 Participants
Cohort 2, Treatment B: TAK-951 1.0 mgNumber of Participants With Clinically Significant Change From Baseline in Vital Sign Values0 Participants
Cohort 3, Treatment C: TAK-951 1.0 mgNumber of Participants With Clinically Significant Change From Baseline in Vital Sign Values0 Participants
Cohort 4, Treatment D: TAK-951 1.0 mgNumber of Participants With Clinically Significant Change From Baseline in Vital Sign Values0 Participants
Secondary

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951

Time frame: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose

Population: The pharmacokinetic (PK) analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Cohorts 1 to 2, Treatment P1: Placebo PooledAUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-9512.758 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 25.1
Cohort 3, Treatment P2: PlaceboAUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951110.4 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 11
Cohort 4, Treatment P3: PlaceboAUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951127.7 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 23.9
Cohort 1, Treatment A: TAK-951 20 mcgAUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951133.2 nanogram*hour per milliliter (ng*hr/mL)Geometric Coefficient of Variation 9.5
Secondary

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-951

Time frame: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose

Population: The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Cohorts 1 to 2, Treatment P1: Placebo PooledAUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-9512.722 ng*hr/mLGeometric Coefficient of Variation 25.4
Cohort 3, Treatment P2: PlaceboAUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-951110.0 ng*hr/mLGeometric Coefficient of Variation 10.8
Cohort 4, Treatment P3: PlaceboAUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-951127.2 ng*hr/mLGeometric Coefficient of Variation 24
Cohort 1, Treatment A: TAK-951 20 mcgAUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-951132.5 ng*hr/mLGeometric Coefficient of Variation 9.5
Secondary

Ceoi: Plasma Concentration at the End of Infusion for TAK-951

Time frame: Day 1: at the end of infusion (at 30 hours post-infusion)

Population: The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951. Here overall number of participants analyzed are those who were evaluable for this outcome measure.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Cohorts 1 to 2, Treatment P1: Placebo PooledCeoi: Plasma Concentration at the End of Infusion for TAK-9510.5203 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 143.2
Cohort 3, Treatment P2: PlaceboCeoi: Plasma Concentration at the End of Infusion for TAK-95148.95 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 15.9
Cohort 4, Treatment P3: PlaceboCeoi: Plasma Concentration at the End of Infusion for TAK-95137.03 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 38.4
Cohort 1, Treatment A: TAK-951 20 mcgCeoi: Plasma Concentration at the End of Infusion for TAK-95127.06 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 9.1
Secondary

Number of Participants With Positive Anti-drug Antibodies (ADA) in Serum

ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.

Time frame: Baseline up to Day 29

Population: The immunogenicity analysis set included those participants from the safety analysis set who had a baseline and at least 1 post-dose immunogenicity sample assessment.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohorts 1 to 2, Treatment P1: Placebo PooledNumber of Participants With Positive Anti-drug Antibodies (ADA) in Serum0 Participants
Cohort 3, Treatment P2: PlaceboNumber of Participants With Positive Anti-drug Antibodies (ADA) in Serum0 Participants
Cohort 4, Treatment P3: PlaceboNumber of Participants With Positive Anti-drug Antibodies (ADA) in Serum0 Participants
Cohort 1, Treatment A: TAK-951 20 mcgNumber of Participants With Positive Anti-drug Antibodies (ADA) in Serum0 Participants
Cohort 2, Treatment B: TAK-951 1.0 mgNumber of Participants With Positive Anti-drug Antibodies (ADA) in Serum0 Participants
Cohort 3, Treatment C: TAK-951 1.0 mgNumber of Participants With Positive Anti-drug Antibodies (ADA) in Serum0 Participants
Cohort 4, Treatment D: TAK-951 1.0 mgNumber of Participants With Positive Anti-drug Antibodies (ADA) in Serum0 Participants
Secondary

T1/2z: Terminal Disposition Phase Half-life for TAK-951

Time frame: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose

Population: The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.

ArmMeasureValue (MEAN)Dispersion
Cohorts 1 to 2, Treatment P1: Placebo PooledT1/2z: Terminal Disposition Phase Half-life for TAK-9514.025 hourStandard Deviation 0.71
Cohort 3, Treatment P2: PlaceboT1/2z: Terminal Disposition Phase Half-life for TAK-9514.670 hourStandard Deviation 0.5576
Cohort 4, Treatment P3: PlaceboT1/2z: Terminal Disposition Phase Half-life for TAK-9514.454 hourStandard Deviation 0.5124
Cohort 1, Treatment A: TAK-951 20 mcgT1/2z: Terminal Disposition Phase Half-life for TAK-9514.640 hourStandard Deviation 0.341
Secondary

λz: Terminal Disposition Phase Rate Constant for TAK-951

Time frame: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose

Population: The PK analysis set consisted of all participants who received the active study drug and had at least one measurable plasma concentration of TAK-951.

ArmMeasureValue (MEAN)Dispersion
Cohorts 1 to 2, Treatment P1: Placebo Pooledλz: Terminal Disposition Phase Rate Constant for TAK-9510.1781 per hour (1/hour)Standard Deviation 0.040265
Cohort 3, Treatment P2: Placeboλz: Terminal Disposition Phase Rate Constant for TAK-9510.1501 per hour (1/hour)Standard Deviation 0.016879
Cohort 4, Treatment P3: Placeboλz: Terminal Disposition Phase Rate Constant for TAK-9510.1574 per hour (1/hour)Standard Deviation 0.018543
Cohort 1, Treatment A: TAK-951 20 mcgλz: Terminal Disposition Phase Rate Constant for TAK-9510.1500 per hour (1/hour)Standard Deviation 0.010488

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026