A Study of TAK-510 in Healthy Adults

NCT ID: NCT04731922

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-03
• Study Completion Date: 2022-07-24

Brief Summary

This is a study of TAK-510 for people with symptoms of feeling sick (nausea) or being sick (vomiting).

The main aims of the study are to check if healthy adults have side effects from TAK-510 and to check how much TAK-510 they can receive without getting side effects from it.

The study will be in 3 parts. Participants will take part in only 1 of the 3 parts of the study.

At the first visit, the study doctor will check if each person can take part. For those who can take part, they will be placed in 1 of many small groups. The 1st groups will join Part 1 of the study, the 2nd groups will join Part 2 and the 3rd groups will join Part 3. They will receive an injection under the skin of either TAK-510 or placebo. In this study, a placebo will look like the TAK-510 injection but will not have any medicine in it.

In Part 1, the 1st group of participants will receive 1 injection of either TAK-510 or placebo. Different participants within this group will receive lower to higher doses of TAK-510. The participants in this group will stay in the clinic for 4 days after their injection for some tests and check for any side effects from their treatment.

In Part 2, the 2nd group of participants will receive an injection of either TAK-510 or placebo, once a day for 5 days. Different participants within this group will receive lower to higher doses of TAK-510. The participants in this group will stay in the clinic for 9 days after their 1st injection for some tests and check for any side effects from their treatment.

In Part 3, the 3rd group of participants will visit the clinic 2 times. At the 1st visit, they will receive an injection either of TAK-510 or placebo, once a day for 7 days. Each participant in this group will receive lower to higher doses of TAK-510. They will stay in the clinic for 8 days after their 1st injection for some tests and check for any side effects from their treatment.

At the 2nd clinic visit, each participant will receive 1 single injection of TAK-510 or placebo. This will happen 7 days after their last injection from the previous clinic visit. They will receive the same dose as their previous dose. They will stay in the clinic for 3 days for some tests and check for any side effects from their treatment.

After treatment, all participants in the study will return to the clinic for a weekly check-up visit for up to 3 weeks.

Detailed Description

The drug being tested in this study is called TAK-510. The study will look at the safety, tolerability, and PK of TAK-510 in healthy participants.

The study will enroll up to approximately 224 healthy participants. Participants in each cohort will be randomized to receive treatment with TAK-510 or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). The study consists of 3 parts and up to 28 cohorts as mentioned below.

• TAK-510, Part 1: Single rising dose (SRD) design to assess the safety, immunogenicity, tolerability, and PK of TAK-510
• TAK-510, Part 2: Multiple rising dose (MRD) design to assess the safety, immunogenicity, tolerability, and PK of TAK-510
• TAK-510, Part 3: Dose titration and redosing design to assess the safety, immunogenicity, tolerability, and PK of TAK-510

This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 57 days. Participants will be followed up for 7 days after the last dose of study drug for a follow-up assessment.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

TAK-510: Part 1

TAK-510 at starting dose of 5 microgram (mcg) or placebo-matching solution, subcutaneously, once on Day 1. Staggered dosing will be done in the first cohort of Part A (Cohort 1). Staggered dosing in subsequent Cohorts (Cohorts 2-12 and 21-25) will be used based on emerging safety, tolerability, and PK data from Cohort 1 as determined in the dose escalation meeting.

Group Type: EXPERIMENTAL

TAK-510

Intervention Type: DRUG

TAK-510 solution.

TAK-510 Placebo

Intervention Type: DRUG

TAK-510 placebo-matching solution.

TAK-510: Part 2

TAK-510 to be decided (TBD) or placebo-matching solution, subcutaneously, once daily from Day 1 through Day 5. Dose of MRD Cohorts (Cohorts 13-17 and 26-28) of Part 2 will be determined based on emerging safety, tolerability, and available PK data from Part 1 (SRD) and any available PK data from Part 2 as determined in the dose escalation meeting.

Group Type: EXPERIMENTAL

TAK-510

Intervention Type: DRUG

TAK-510 solution.

TAK-510 Placebo

Intervention Type: DRUG

TAK-510 placebo-matching solution.

TAK-510: Part 3

TAK-510 TBD or placebo-matching solution, subcutaneously, once daily from Days 1 to 7. Dose of dose titration and redosing Cohorts (Cohorts 18-20) of Part 3 will be based on emerging safety, tolerability, and available PK data from Part 1 (SRD) and Part 2 (MRD) as determined in the dose escalation meeting. Single redosing will be performed on Day 14 after 7 days of washout period following the 7 days treatment period.

Group Type: EXPERIMENTAL

TAK-510

Intervention Type: DRUG

TAK-510 solution.

TAK-510 Placebo

Intervention Type: DRUG

TAK-510 placebo-matching solution.

Interventions

TAK-510

TAK-510 solution.

Intervention Type: DRUG

TAK-510 Placebo

TAK-510 placebo-matching solution.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing and throughout the study.
• Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2) at the screening visit.

Exclusion Criteria

• Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody/antigen, at the screening visit.
• Had major surgery or donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the screening visit.
• Unable to refrain from or anticipates using all medications including herbal medicines beginning approximately 7 days before administration of the first dose of study drug, throughout the study until 2 days after discharge.
• Unable to refrain from or anticipates using marijuana or cannabis-containing products beginning approximately 7 days before administration of the first dose of study drug, throughout the study until after the last PK dose.
• Has had a previous major psychotic disorder.
• Has an average semirecumbent blood pressure (BP) less than 90/60 millimeter of mercury (mmHg) or greater than 140/90 mmHg from screening to predose, inclusive. Any assessments on Day -1, where 2 consecutive time point values do not meet this criterion must be discussed with the medical monitor for approval.
• Has orthostatic hypotension defined as a decrease in systolic BP >=20 mmHg or a decrease in diastolic BP >=10 mmHg at approximately 3 minutes of standing when compared with BP from the semirecumbent position, at screening to predose assessments, inclusive. In asymptomatic participants, any assessments after screening that do not meet this criterion may be repeated after the participant has remained in the semirecumbent or supine position for 15 minutes. If the repeat assessment is exclusionary based on the above criterion, the participant will not be eligible. If the repeat assessment is not exclusionary, the participant will be eligible.
• Has postural orthostatic tachycardia, defined as an increase of greater than (>) 30 beats per minute (bpm) or heart rate (HR) >120 bpm at approximately 3 minutes, of standing, at screening to predose assessments, inclusive. Any assessments after screening that do not meet this criterion may be repeated with the participant remaining standing for up to a total of 5 minutes, provided that the participant remains asymptomatic. If the repeat assessment occurring within 5 minutes is exclusionary based on the above criterion, the participant will not be eligible. A confirmed orthostatic increase of >30 bpm, but less than (<) 40 bpm, on 1 or more Day -1 assessments may not be considered exclusionary if not considered clinically significant by the investigator and the medical monitor. Such assessments must be discussed with the medical monitor prior to determination that the participant is eligible to proceed.
• Has a known or suspected current coronavirus disease 2019 (COVID-19) infection or is at risk of COVID-19 infection as assessed by the investigator.

• 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

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

PPD Development, LP

Las Vegas, Nevada, United States

PPD Development, LP

Austin, Texas, 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/602005c75f53e3001ed0d7bc

To obtain more information on the study, click on this link

Other Identifiers

U1111-1261-6974

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-510-1001

Identifier Type: -

Identifier Source: org_study_id