Clinical trial NCT05818956: A Study of TAK-227 in Healthy Adults
Official title: A Randomized, Open-label, Single-dose, Three-way Crossover Evaluation of the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of TAK-227 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax: Maximum Observed Plasma Concentration for TAK-227
timeFrame: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-227
timeFrame: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-227
timeFrame: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
Secondary outcomes:
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: From start of study drug administration up to 7 days after the last dose (up to Day 20)
measure: Number of Participants Based on Severity of TEAE
timeFrame: From start of study drug administration up to 7 days after the last dose (up to Day 20)
measure: Number of Participants Based on Causality of TEAEs
timeFrame: From start of study drug administration up to 7 days after the last dose (up to Day 20)
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
timeFrame: Baseline to Day 13
measure: Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECG) Values
timeFrame: Baseline to Day 13
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
timeFrame: Baseline to Day 13
measure: Number of Participants With Clinically Significant Change From Baseline in Physical Examination
timeFrame: Baseline to Day 13
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion, Inc.
state: Arizona
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: