Recent Updates
Recently added Catalysts

TAK-227

Phase 1

Healthy Volunteers | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Aug 6, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

TAK-227 · 1 trial · 1 indication

Phase 1 1
NCT05818956A Study of TAK-227 in Healthy AdultsHealthy Volunteers
COMPLETED24 Analytics
PHASE1COMPLETED
A Study of TAK-227 in Healthy Adults
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax: Maximum Observed Plasma Concentration for TAK-227
Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-227
Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-227
Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose

Secondary Endpoints

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
From start of study drug administration up to 7 days after the last dose (up to Day 20)
Number of Participants Based on Severity of TEAE
From start of study drug administration up to 7 days after the last dose (up to Day 20)
Number of Participants Based on Causality of TEAEs
From start of study drug administration up to 7 days after the last dose (up to Day 20)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence 1: (Treatment A + Treatment B + Treatment C)EXPERIMENTALTAK-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.
Sequence 2: (Treatment B + Treatment C + Treatment A)EXPERIMENTALTAK-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.
Sequence 3: (Treatment C + Treatment A + Treatment B)EXPERIMENTALTAK-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.
Sequence 4: (Treatment A + Treatment C + Treatment B)EXPERIMENTALTAK-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.
Sequence 5: (Treatment B + Treatment A + Treatment C)EXPERIMENTALTAK-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.
Sequence 6: (Treatment C + Treatment B + Treatment A)EXPERIMENTALTAK-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.

Interventions

NameTypeDescription
TAK-227DRUGTAK-227 capsules.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria Participants must fulfill the following inclusion criteria to be eligible for participation in the study: * Body mass index (BMI) greater than or equal to (\>=) 18 and less than or equal to (\<=) 32.0 kilogram per square meter (kg/m\^2) at screening visit. * Continuous non-smoke...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about TAK-227

What is TAK-227?

TAK-227 is an investigational small molecule being developed by Takeda Pharmaceutical Company Limited. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is classified as Other. TAK-227 is not approved and remains in clinical investigation.

What is TAK-227 used for?

TAK-227 is being studied for use in healthy volunteers. The completed Phase 1 trial, NCT05818956, enrolled healthy adults to evaluate the drug. As an investigational agent, its potential therapeutic use has not been established, and it is not approved for any condition.

Who makes TAK-227?

TAK-227 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical trial for this investigational small molecule. The drug is currently in Phase 1 development.

What phase is TAK-227 in?

TAK-227 is in Phase 1 clinical development. A single Phase 1 trial, NCT05818956, has been completed. The drug is investigational and has not been approved by regulatory authorities. It remains in early-stage clinical testing.

What clinical trials is TAK-227 in?

TAK-227 has one completed Phase 1 clinical trial, NCT05818956, titled "A Study of TAK-227 in Healthy Adults." This trial enrolled 24 participants in the United States, with ages 18 years and older. The trial was controlled and randomized, though not double-blinded.

Is TAK-227 the same as any other drug?

TAK-227 is the only name provided for this investigational drug. No alternative names have been identified for this small molecule being developed by Takeda. It is currently in Phase 1 clinical development for healthy volunteers.