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TAK-227 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sequence 1: (Treatment A + Treatment B + Treatment C) | EXPERIMENTAL | 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. |
| Sequence 2: (Treatment B + Treatment C + Treatment A) | EXPERIMENTAL | 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. |
| Sequence 3: (Treatment C + Treatment A + Treatment B) | EXPERIMENTAL | 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. |
| Sequence 4: (Treatment A + Treatment C + Treatment B) | EXPERIMENTAL | 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. |
| Sequence 5: (Treatment B + Treatment A + Treatment C) | EXPERIMENTAL | 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. |
| Sequence 6: (Treatment C + Treatment B + Treatment A) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| TAK-227 | DRUG | TAK-227 capsules. |
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...
TAK-227 is an investigational small molecule developed by Takeda Pharmaceutical Company Limited. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. TAK-227 remains in clinical development and is not an approved medicine.
TAK-227 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the Phase 1 study of TAK-227 conducted in healthy adult volunteers in the United States.
TAK-227 is in Phase 1 clinical development. Its only recorded trial, NCT05818956, was a completed Phase 1 study in healthy adults. TAK-227 is investigational and has not been approved by the FDA for any use.
TAK-227 has been evaluated in one clinical trial, NCT05818956, titled A Study of TAK-227 in Healthy Adults. That Phase 1 trial was completed, enrolled 24 participants, used a controlled and randomized design, and was conducted in the United States with healthy volunteers aged 18 years and older.
No. TAK-227 is an investigational small molecule in Phase 1 clinical development and has not been approved by the FDA. Its only recorded study, NCT05818956, was a completed Phase 1 trial in healthy adult volunteers, so the asset remains in early-stage clinical research.
The Phase 1 trial of TAK-227, NCT05818956, enrolled 24 participants. The study was randomized and controlled, was not double blind, and was conducted in the United States in healthy volunteers aged 18 years and older. The trial has been completed.