Healthy VolunteersPhase 1NCT05567393
A Study of TAK-951 in Healthy Adults
A Phase 1 study testing TAK-951 in people with Healthy Volunteers, run by Takeda at 1 site in United States.
Trial summary
This is a study of TAK-951 for people with symptoms of nausea and vomiting. The main aims of this study in healthy adults 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TAK-951
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2019to 2 Nov 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Have a body mass index (BMI) ≥18 and ≤30.0 (kg/m^2) at the Screening Visit.
Who cannot join
- The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody/antigen, at the Screening Visit. Note: Participants with positive hepatitis B virus or hepatitis C virus serology may be enrolled if quantitative polymerase chain reaction for hepatitis B virus or hepatitis C virus ribonucleic acid is negative.
- The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the Screening Visit.
- Heavy consumption of alcohol within 3 months before screening (>7 drinks/week for women, >14 drinks/week for men, where 1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) or use of soft drugs (such as marijuana) within 3 months before screening, or hard drugs (such as cocaine and phencyclidine) within 1 year before Screening.
- The participant has used nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 28 days before check-in (Day -1) or cotinine test is positive at Screening or Day -1.
- The participant has had 3 incidences of vasovagal syncope within the last 5 years.
- The participant has Brugada syndrome (right bundle branch block [RBBB] pattern with ST-elevation in leads V1-V3).
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- The participant has an average semirecumbent systolic blood pressure <90 millimeters of mercury (mm Hg) or diastolic blood pressure <60 mm Hg at Screening or admission.
- The participant has an average heart rate (HR) <60 or >100 beats per minute (bpm) [at Screening, at Day -1, or at predose]; athletic participants with an average HR <60 bpm can be enrolled only with medical monitor approval.
- The participant has orthostatic hypotension defined as a decrease in systolic blood pressure ≥20 mm Hg or a decrease in diastolic blood pressure ≥10 mm Hg after 2 minutes of standing when compared with blood pressure from the sitting position at Screening, and at Day -1. Participants with postural orthostatic tachycardia, defined as HR >120 bpm standing, will also be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials Medical Group
Glendale, California, 91206
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Three-part Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-951 in Healthy Subjects
This is a study of TAK-951 for people with symptoms of nausea and vomiting. The main aims of this study in healthy adults 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.
- To check how much TAK-951 stays in the blood over time to work out the best dose.
Read more
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.
Read the detailed description
The drug being tested in this study is called TAK-951. The study evaluated the safety, tolerability and pharmacokinetics (PK) of TAK-951 in healthy participants.
The study enrolled 128 healthy participants and consisted of 2 parts: Single-rising Dose (SRD) part (13 cohorts) of sequential panel design, and Multiple-rising Dose (MRD) part (5 cohorts) of sequential panel design. Participants in each cohort were randomized to receive treatment with TAK-951 or matching placebo using SC injection, once daily on Day 1 (for SRD part) and twice daily (BID) on Days 1 through 5 (for MRD part) following a minimum fast of 8 hours.
This single center trial was conducted in the United States. The overall time to participate in this study was approximately 155 days.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-951 Placebo, TAK-951
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-951 PlaceboDrug
TAK-951 placebo-matching SC injection
TAK-951Drug
TAK-951 SC injection
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (SRD): Pooled Placebo | Placebo comparator | TAK-951 placebo-matching, single dose, subcutaneous (SC) injection, on Day 1 in fasted healthy participants in the single-rising dose (SRD) period. Receives: Drug: TAK-951 Placebo |
| Part 1 (SRD): Cohort 2: TAK-951 Dose 1 | Experimental | TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. Receives: Drug: TAK-951 |
| Part 1 (SRD): Cohort 1: TAK-951 Dose 2 | Experimental | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. Receives: Drug: TAK-951 |
| Part 1 (SRD): Cohort 15: TAK-951 Dose 2 | Experimental | TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. Receives: Drug: TAK-951 |
| Part 1 (SRD): Cohort 3: TAK-951 Dose 3 | Experimental | TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. Receives: Drug: TAK-951 |
| Part 1 (SRD): Cohort 4: TAK-951 Dose 4 | Experimental | TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. Receives: Drug: TAK-951 |
| Part 1 (SRD): Cohort 5: TAK-951 Dose 5 | Experimental | TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. Receives: Drug: TAK-951 |
| Part 1 (SRD): Cohort 6: TAK-951 Dose 6 | Experimental | TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. Receives: Drug: TAK-951 |
| Part 1 (SRD): Cohort 13: TAK-951 Dose 7 | Experimental | TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. Receives: Drug: TAK-951 |
| Part 1 (SRD): Cohort 14: TAK-951 Dose 8 | Experimental | TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. Receives: Drug: TAK-951 |
| Part 1 (SRD): Cohort 16: TAK-951 Dose 9 | Experimental | TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. Receives: Drug: TAK-951 |
| Part 1 (SRD): Cohort 17: TAK-951 Dose 10 | Experimental | TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. Receives: Drug: TAK-951 |
| Part 1 (SRD): Cohort 18: TAK-951 Dose 11 | Experimental | TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. Receives: Drug: TAK-951 |
| Part 3 (MRD): Pooled Placebo | Placebo comparator | TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the multiple-rising dose (MRD) period. Receives: Drug: TAK-951 Placebo |
| Part 3 (MRD): Cohort 10: TAK-951 Dose 1A | Experimental | TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. Receives: Drug: TAK-951 |
| Part 3 (MRD): Cohort 11: TAK-951 Dose 2A | Experimental | TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. Receives: Drug: TAK-951 |
| Part 3 (MRD): Cohort 12: TAK-951 Dose 3A | Experimental | TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. Receives: Drug: TAK-951 |
| Part 3 (MRD): Cohort 20: TAK-951 Dose 4A | Experimental | TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. Receives: Drug: TAK-951 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1 and 3: Percentage of Participants With Clinically Significant Physical Examination Findings
Physical examination included the examination of the abdomen; extremities; head, eyes, ears, nose (HEENT); neurological; skin and mucosae; thorax.
Measured: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Vital Signs Parameters
The criteria for markedly abnormal values of vital signs' parameters were: Pulse Rate (beats/minute) <50 and >120; Systolic Blood Pressure [millimeters of mercury (mmHg)] <85 and >180; Diastolic Blood Pressure (mmHg) <50 and >110; Temperature [degrees Celsius (C)] <35.6 and >37.7. Only categories with atleast one participant with events are reported.
Measured: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters
The criteria for markedly abnormal values of 12-lead ECG parameters were: ECG Mean Heart Rate (beats/min) <50 beats per minute and >120 beats per minute; PR Interval, Aggregate [milliseconds (msec)] <=80 msec and >=200 msec; QRS Duration, Aggregate (msec) <=80 msec and >=120 msec; QT Interval with Fridericia Correction Method (QTcF) Interval, Aggregate (msec) >=500 msec or >=30 msec change from Baseline and >=450 msec. Only categories with atleast one participant with event are reported.
Measured: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Laboratory Parameters
The laboratory parameters of chemistry, and hematology were assessed. Clinical laboratory tests included serum chemistry, hematology, and urinalysis. MAV criteria: Alanine aminotransferase(U/L) >3xupper limit of normal(ULN); Albumin<2.5g/dL,<25g/L; Alkaline phosphatase (U/L)>3 x ULN; Aspartate aminotransferase (U/L)>3 x ULN; Bilirubin>1.5mg/dL, >34.2 µmol/L; Calcium<8.0 mg/dL,LLN-<2.0mmol/L, >1.0mmol/L; Carbon dioxide <8.0 (mmol/L); Chloride<75 mmol/L,>126 mmol/L; Creatinine>177µmol/L; Gamma glutamyl transferase (U/L)>2.0 mg/dL, >3.0 x ULN; Glucose<3 mmol/L,>10 mmol/L; Potassium<3.0 mmol/L >5.5 mmol/L; Protein(g/L)<0.8 x LLN >1.2 x ULN; Sodium<130mmol/L >150mmol/L; Urea nitrogen >10.7; Erythrocytes 10^12erythrocytes/L) <0.8 x LLN,>1.2 x ULN; Hematocrit(%) <0.8 x LLN,>1.2xULN; Hemoglobin(g/L)<0.8 x LLN, >1.2 x ULN; Leukocytes(10^9 leukocytes/L)<0.5 x LLN >1.5 x ULN; platelets(10^9 platelets/L)<75->600. Only categories with atleast one participant with event are reported.
Measured: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)
Parts 1 and 3: Percentage of Participants With Treatment-Emergent Adverse Events
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 (example, 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 TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug.
Measured: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)
Parts 1 and 3: Percentage of Participants With Positive Immunogenicity (ADA) Status
Measured: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)
Secondary outcomes (4)
Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-951
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Part 1
Part 1: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Part 1
Part 3: Cmax: Maximum Observed Plasma Concentration for TAK-951 on Day 1
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose on Day 1 in Part 3
Part 3: AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval Tau (τ), From Time of First Daily Dose to 8 Hours for TAK-951 on Day 1
Measured: Pre-dose and at multiple time points (up to 24 hours) post-dose on Day 1 in Part 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start7 Mar 2019
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567393
- Sponsor's protocol ID
- TAK-951-1001
- Status last verified
- Nov 2022
- First submitted
- 25 Oct 2021
- Last updated
- 14 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment? commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Three-part Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-951 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05567393
- Acronym / sponsor ID
- TAK-951-1001
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Posted 14 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of TAK-951 for people with symptoms of nausea and vomiting. The main aims of this study in healthy adults 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.
- To check how much TAK-951 stays in the blood over time to work out the best dose.
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 evaluated the safety, tolerability and pharmacokinetics (PK) of TAK-951 in healthy participants.
The study enrolled 128 healthy participants and consisted of 2 parts: Single-rising Dose (SRD) part (13 cohorts) of sequential panel design, and Multiple-rising Dose (MRD) part (5 cohorts) of sequential panel design. Participants in each cohort were randomized to receive treatment with TAK-951 or matching placebo using SC injection, once daily on Day 1 (for SRD part) and twice daily (BID) on Days 1 through 5 (for MRD part) following a minimum fast of 8 hours.
This single center trial was conducted in the United States. The overall time to participate in this study was approximately 155 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Part 1 (SRD): Pooled Placebo | Placebo comparator | Drug: TAK-951 PlaceboTAK-951 placebo-matching, single dose, subcutaneous (SC) injection, on Day 1 in fasted healthy participants in the single-rising dose (SRD) period. |
| Part 1 (SRD): Cohort 2: TAK-951 Dose 1 | Experimental | Drug: TAK-951TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| Part 1 (SRD): Cohort 1: TAK-951 Dose 2 | Experimental | Drug: TAK-951TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| Part 1 (SRD): Cohort 15: TAK-951 Dose 2 | Experimental | Drug: TAK-951TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| Part 1 (SRD): Cohort 3: TAK-951 Dose 3 | Experimental | Drug: TAK-951TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| Part 1 (SRD): Cohort 4: TAK-951 Dose 4 | Experimental | Drug: TAK-951TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| Part 1 (SRD): Cohort 5: TAK-951 Dose 5 | Experimental | Drug: TAK-951TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| Part 1 (SRD): Cohort 6: TAK-951 Dose 6 | Experimental | Drug: TAK-951TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| Part 1 (SRD): Cohort 13: TAK-951 Dose 7 | Experimental | Drug: TAK-951TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| Part 1 (SRD): Cohort 14: TAK-951 Dose 8 | Experimental | Drug: TAK-951TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| Part 1 (SRD): Cohort 16: TAK-951 Dose 9 | Experimental | Drug: TAK-951TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| Part 1 (SRD): Cohort 17: TAK-951 Dose 10 | Experimental | Drug: TAK-951TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| Part 1 (SRD): Cohort 18: TAK-951 Dose 11 | Experimental | Drug: TAK-951TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period. |
| Part 3 (MRD): Pooled Placebo | Placebo comparator | Drug: TAK-951 PlaceboTAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the multiple-rising dose (MRD) period. |
| Part 3 (MRD): Cohort 10: TAK-951 Dose 1A | Experimental | Drug: TAK-951TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| Part 3 (MRD): Cohort 11: TAK-951 Dose 2A | Experimental | Drug: TAK-951TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| Part 3 (MRD): Cohort 12: TAK-951 Dose 3A | Experimental | Drug: TAK-951TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
| Part 3 (MRD): Cohort 20: TAK-951 Dose 4A | Experimental | Drug: TAK-951TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Have a body mass index (BMI) ≥18 and ≤30.0 (kg/m^2) at the Screening Visit.
Key exclusion criteria (9 listed)
- The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody/antigen, at the Screening Visit. Note: Participants with positive hepatitis B virus or hepatitis C virus serology may be enrolled if quantitative polymerase chain reaction for hepatitis B virus or hepatitis C virus ribonucleic acid is negative.
- The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the Screening Visit.
- Heavy consumption of alcohol within 3 months before screening (>7 drinks/week for women, >14 drinks/week for men, where 1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) or use of soft drugs (such as marijuana) within 3 months before screening, or hard drugs (such as cocaine and phencyclidine) within 1 year before Screening.
- The participant has used nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 28 days before check-in (Day -1) or cotinine test is positive at Screening or Day -1.
- The participant has had 3 incidences of vasovagal syncope within the last 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-951 PlaceboTAK-951 placebo-matching SC injection | Drug | Part 1 (SRD): Pooled Placebo, Part 3 (MRD): Pooled Placebo |
| TAK-951TAK-951 SC injection | Drug | Part 1 (SRD): Cohort 13: TAK-951 Dose 7, Part 1 (SRD): Cohort 14: TAK-951 Dose 8, Part 1 (SRD): Cohort 15: TAK-951 Dose 2, Part 1 (SRD): Cohort 16: TAK-951 Dose 9, Part 1 (SRD): Cohort 17: TAK-951 Dose 10, Part 1 (SRD): Cohort 18: TAK-951 Dose 11, Part 1 (SRD): Cohort 1: TAK-951 Dose 2, Part 1 (SRD): Cohort 2: TAK-951 Dose 1, Part 1 (SRD): Cohort 3: TAK-951 Dose 3, Part 1 (SRD): Cohort 4: TAK-951 Dose 4, Part 1 (SRD): Cohort 5: TAK-951 Dose 5, Part 1 (SRD): Cohort 6: TAK-951 Dose 6, Part 3 (MRD): Cohort 10: TAK-951 Dose 1A, Part 3 (MRD): Cohort 11: TAK-951 Dose 2A, Part 3 (MRD): Cohort 12: TAK-951 Dose 3A, Part 3 (MRD): Cohort 20: TAK-951 Dose 4A |
Primary outcome
Parts 1 and 3: Percentage of Participants With Clinically Significant Physical Examination Findings
Time frame: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)
Physical examination included the examination of the abdomen; extremities; head, eyes, ears, nose (HEENT); neurological; skin and mucosae; thorax.
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Vital Signs Parameters
Time frame: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)
The criteria for markedly abnormal values of vital signs' parameters were: Pulse Rate (beats/minute) <50 and >120; Systolic Blood Pressure [millimeters of mercury (mmHg)] <85 and >180; Diastolic Blood Pressure (mmHg) <50 and >110; Temperature [degrees Celsius (C)] <35.6 and >37.7. Only categories with atleast one participant with events are reported.
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters
Time frame: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)
The criteria for markedly abnormal values of 12-lead ECG parameters were: ECG Mean Heart Rate (beats/min) <50 beats per minute and >120 beats per minute; PR Interval, Aggregate [milliseconds (msec)] <=80 msec and >=200 msec; QRS Duration, Aggregate (msec) <=80 msec and >=120 msec; QT Interval with Fridericia Correction Method (QTcF) Interval, Aggregate (msec) >=500 msec or >=30 msec change from Baseline and >=450 msec. Only categories with atleast one participant with event are reported.
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Laboratory Parameters
Time frame: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)
The laboratory parameters of chemistry, and hematology were assessed. Clinical laboratory tests included serum chemistry, hematology, and urinalysis. MAV criteria: Alanine aminotransferase(U/L) >3xupper limit of normal(ULN); Albumin<2.5g/dL,<25g/L; Alkaline phosphatase (U/L)>3 x ULN; Aspartate aminotransferase (U/L)>3 x ULN; Bilirubin>1.5mg/dL, >34.2 µmol/L; Calcium<8.0 mg/dL,LLN-<2.0mmol/L, >1.0mmol/L; Carbon dioxide <8.0 (mmol/L); Chloride<75 mmol/L,>126 mmol/L; Creatinine>177µmol/L; Gamma glutamyl transferase (U/L)>2.0 mg/dL, >3.0 x ULN; Glucose<3 mmol/L,>10 mmol/L; Potassium<3.0 mmol/L >5.5 mmol/L; Protein(g/L)<0.8 x LLN >1.2 x ULN; Sodium<130mmol/L >150mmol/L; Urea nitrogen >10.7; Erythrocytes 10^12erythrocytes/L) <0.8 x LLN,>1.2 x ULN; Hematocrit(%) <0.8 x LLN,>1.2xULN; Hemoglobin(g/L)<0.8 x LLN, >1.2 x ULN; Leukocytes(10^9 leukocytes/L)<0.5 x LLN >1.5 x ULN; platelets(10^9 platelets/L)<75->600. Only categories with atleast one participant with event are reported.
Parts 1 and 3: Percentage of Participants With Treatment-Emergent Adverse Events
Time frame: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)
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 (example, 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 TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug.
Parts 1 and 3: Percentage of Participants With Positive Immunogenicity (ADA) Status
Time frame: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)
4 secondary outcomes
Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-951
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Part 1
Part 1: 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 48 hours) post-dose in Part 1
Part 3: Cmax: Maximum Observed Plasma Concentration for TAK-951 on Day 1
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose on Day 1 in Part 3
Part 3: AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval Tau (τ), From Time of First Daily Dose to 8 Hours for TAK-951 on Day 1
Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose on Day 1 in Part 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information about this study, click this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment? commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-951 in people with Healthy Volunteers, run by Takeda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts 1 and 3: Percentage of Participants With Clinically Significant Physical Examination Findings (time frame: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.