A Study of TAK-227 in Healthy Adults

Takeda24 enrolled

Overview

The main aim of this study is to test the effects of food consumption with sponsor compound TAK-227 in healthy participants. The study will also measure side effects, and to check how much TAK-227 stays in the blood over time to work out the best dose.

The drug being tested in this study is called TAK-227. This study will assess the effect of food on single-dose of TAK-227 in healthy participants. The study will enroll approximately 24 participants. A single dose of 50 milligram (mg) TAK-227 will be administered orally under one of 3 different feeding conditions. * Fasting (Treatment A), * Fed following a high-fat or high-calorie meal prior to dosing (Treatment B), and * Fed following a high-fat or high-calorie meal after dosing (Treatment C) Participants will be randomly assigned to 1 of the 6 treatments sequences based on the 3 feeding conditions. * Sequence 1: (Treatment A + Treatment B + Treatment C) * Sequence 2: (Treatment B + Treatment C + Treatment A) * Sequence 3: (Treatment C + Treatment A + Treatment B) * Sequence 4: (Treatment A + Treatment C + Treatment B) * Sequence 5: (Treatment B + Treatment A + Treatment C) * Sequence 6: (Treatment C + Treatment B + Treatment A) All participants will receive all 6 treatment regimens. This is a single-center trial. Participants will be followed up for up to 7 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 40 days including screening period and follow-up period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

TAK-227DRUG

TAK-227 capsules.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on participant self-reporting. Exclusion Criteria: Participants must not be enrolled in the study if they meet any of the following criteria: * Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. * Drink alcohol in excess of 21 units per week for males or 14 units per week for females, with one unit equal to (=) 150 milliliter (mL) of wine or 360 mL of beer or 45 mL of 45 percent (%) alcohol. * Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV). * Unable to refrain from or anticipates the use of: * Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. Medication listed as part of acceptable birth control methods will be allowed. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration. Hormone replacement therapy will also be allowed. * Any drugs known to be significant inducers or inhibitors of Cytochrome P450 (CYP)3A4 enzymes and/or P-glycoprotein (gp), including St. John's Wort, within 28 days prior to the first dosing and throughout the study. Appropriate sources (example, Flockhart Table TM) will be consulted to confirm lack of pharmacokinetic (PK)/pharmacodynamics interaction with study drug. * Chronic use of non-steroidal anti-inflammatory (define as more that 7 days of use) within 2 weeks prior to screening and throughout the study. * Donation of blood or significant blood loss within 56 days prior to the first dosing. * Plasma donation within 7 days prior to the first dosing.

Locations (1)

Celerion, Inc.

Tempe, Arizona, United States

Outcomes

Primary Outcomes

Cmax: Maximum Observed Plasma Concentration for TAK-227

Time frame: 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

Time frame: 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

Time frame: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose

Secondary Outcomes

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

An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who had signed the informed consent form (ICF) to participate in a study; it did not necessarily have to have a causal relationship with the treatment. An SAE was any untoward medical occurrence that at any dose met one or more of the following criteria: resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.

Time frame: 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

Severity of a TEAEs were determined by following criteria: Mild: event that did not generally interfere with usual activities of daily living; Moderate: event that interfere with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupt usual activities of daily living, significantly affects clinical status, or might require intensive therapeutic intervention.

Data from ClinicalTrials.gov

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