A Study of TAK-951 in Healthy Adults

NCT ID: NCT05567393

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-07
• Study Completion Date: 2020-11-02

Brief 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.
• 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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part 1 (SRD): Pooled Placebo

TAK-951 placebo-matching, single dose, subcutaneous (SC) injection, on Day 1 in fasted healthy participants in the single-rising dose (SRD) period.

Group Type: PLACEBO_COMPARATOR

TAK-951 Placebo

Intervention Type: DRUG

TAK-951 placebo-matching SC injection

Part 1 (SRD): Cohort 2: TAK-951 Dose 1

TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 1 (SRD): Cohort 1: TAK-951 Dose 2

TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 1 (SRD): Cohort 15: TAK-951 Dose 2

TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 1 (SRD): Cohort 3: TAK-951 Dose 3

TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 1 (SRD): Cohort 4: TAK-951 Dose 4

TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 1 (SRD): Cohort 5: TAK-951 Dose 5

TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 1 (SRD): Cohort 6: TAK-951 Dose 6

TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 1 (SRD): Cohort 13: TAK-951 Dose 7

TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 1 (SRD): Cohort 14: TAK-951 Dose 8

TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 1 (SRD): Cohort 16: TAK-951 Dose 9

TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 1 (SRD): Cohort 17: TAK-951 Dose 10

TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 1 (SRD): Cohort 18: TAK-951 Dose 11

TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 3 (MRD): Pooled Placebo

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.

Group Type: PLACEBO_COMPARATOR

TAK-951 Placebo

Intervention Type: DRUG

TAK-951 placebo-matching SC injection

Part 3 (MRD): Cohort 10: TAK-951 Dose 1A

TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 3 (MRD): Cohort 11: TAK-951 Dose 2A

TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 3 (MRD): Cohort 12: TAK-951 Dose 3A

TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Part 3 (MRD): Cohort 20: TAK-951 Dose 4A

TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.

Group Type: EXPERIMENTAL

TAK-951

Intervention Type: DRUG

TAK-951 SC injection

Interventions

TAK-951 Placebo

TAK-951 placebo-matching SC injection

Intervention Type: DRUG

TAK-951

TAK-951 SC injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Have a body mass index (BMI) ≥18 and ≤30.0 (kg/m^2) at the Screening Visit.

Exclusion Criteria

1. 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.

2. The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the Screening Visit.

3. 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.

4. 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.

5. The participant has had 3 incidences of vasovagal syncope within the last 5 years.

6. The participant has Brugada syndrome (right bundle branch block [RBBB] pattern with ST-elevation in leads V1-V3).

7. 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.

8. 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.

9. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

California Clinical Trials Medical Group

Glendale, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/70abfd11a4c846d2?idFilter=%5B%22TAK-951-1001%22%5D

To obtain more information about this study, click this link.

Other Identifiers

TAK-951-1001

Identifier Type: -

Identifier Source: org_study_id