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Sequence 1: (Treatment A + Treatment B + Treatment C) for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of study drug administration up to 7 days after the last dose (up to day 16)

Awards & highlights

Study Summary

This trial tests the effects and side effects of a compound (TAK-227) in healthy people to find the best dose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of study drug administration up to 7 days after the last dose (up to day 16)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of study drug administration up to 7 days after the last dose (up to day 16)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study drug administration up to 7 days after the last dose (up to day 16) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-227

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-227

Cmax: Maximum Observed Plasma Concentration for TAK-227

Secondary outcome measures

Number of Participants Based on Causality of TEAE

Number of Participants Based on Severity of TEAE

Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious TEAE

+4 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Sequence 6: (Treatment C + Treatment B + Treatment A)Experimental Treatment1 Intervention

TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 under fasting condition as Treatment A. There will be a washout period of at least 4 days between each dosing.

Group II: Sequence 5: (Treatment B + Treatment A + Treatment C)Experimental Treatment1 Intervention

TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 under fasting condition as Treatment A, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C. There will be a washout period of at least 4 days between each dosing.

Group III: Sequence 4: (Treatment A + Treatment C + Treatment B)Experimental Treatment1 Intervention

TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 under fasting condition as Treatment A, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B. There will be a washout period of at least 4 days between each dosing.

Group IV: Sequence 3: (Treatment C + Treatment A + Treatment B)Experimental Treatment1 Intervention

TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 under fasting condition as Treatment A, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B. There will be a washout period of at least 4 days between each dosing.

Group V: Sequence 2: (Treatment B + Treatment C + Treatment A)Experimental Treatment1 Intervention

TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 under fasting condition as Treatment A . There will be a washout period of at least 4 days between each dosing.

Group VI: Sequence 1: (Treatment A + Treatment B + Treatment C)Experimental Treatment1 Intervention

TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 under fasting condition as Treatment A, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C. There will be a washout period of at least 4 days between each dosing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-227

2023

Completed Phase 1

~30

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TakedaLead Sponsor

1,202 Previous Clinical Trials

4,178,238 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,207 Previous Clinical Trials

489,656 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my profile meet the prerequisites for participation in this medical experiment?

"To partake in this study, applicants must be of sound health and fall within the 18-55 age range. In total, 24 individuals will be selected for participation."

Answered by AI

Has the combination of Treatment A, B, and C in Sequence 1 been given regulatory approval by the FDA?

"Based on our assessment at Power, Sequence 1: (Treatment A + Treatment B + Treatment C) was given a score of one as this is an early-stage clinical trial. This implies that there may be limited data regarding its efficacy and safety."

Answered by AI

Are there any vacancies available for participants in this investigation?

"This investigation, as listed on clinicaltrials.gov, is not presently looking to enroll participants; however it was initially posted May 26th of 2023 and last updated April 6th of the same year. Despite this trial's closure for enrollment purposes, 813 other trials are actively seeking volunteers."

Answered by AI

Does this investigation accept participants beyond the age of thirty?

"In order to be considered, prospective participants must age between 18 and 55. Separately, there are 56 clinical trials aimed at minors while 368 apply to seniors older than 65 years of age."

Answered by AI

What accomplishments does this experiment hope to realize?

"The overarching aim of this controlled clinical trial, which will assess its efficacy over the Day 1 pre-dose and up to 36 hours post-dose timeframes, is to determine the Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration for TAK-227. Additionally, secondary objectives include evaluating participant severity of TEAEs (Mild: event that does not generally interfere with usual activities of daily living; Moderate: event that interferes with usual activities of daily living, causing discomfort or permanent risk; Severe: AE interrupts regular activity and affects current status), assessing causality between"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of TAK-227 in Healthy Adults

2023. "A Study of TAK-227 in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05818956.