A Study of TAK-227 in Healthy Adults

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05818956
• Other study ID #: TAK-227-1001
• Status: Completed
• Phase: Phase 1
• Start date: May 25, 2023
• Est. completion date: June 26, 2023

Study information

• Verified date: August 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 26, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• TAK-227
TAK-227 capsules.

Locations

Country	Name	City	State
United States	Celerion, Inc.	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax: Maximum Observed Plasma Concentration for TAK-227		Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
Primary	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
Primary	AUC8: 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	Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious TEAE	An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed the informed consent form (ICF) to participate in a study and it does not necessarily have to have a causal relationship with the treatment. An SAE is any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.	From start of study drug administration up to 7 days after the last dose (up to Day 16)
Secondary	Number of Participants Based on Severity of TEAE	Severity of a TEAE will be determined by following criteria: 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, permanent risk of harm; Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.	From start of study drug administration up to 7 days after the last dose (up to Day 16)
Secondary	Number of Participants Based on Causality of TEAE	Causality of TEAE to the study medication will be assessed using the following categories: Related: An AE that follows a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which a causal relationship is at least a reasonable possibility, that is, the relationship cannot be ruled out, although factors other than the drug, such as underlying diseases, complications, concomitant drugs and concurrent treatments, may also be responsible; Not Related: An AE that does not follow a reasonable temporal sequence from administration of a drug and/or that can reasonably be explained by other factors, such as underlying diseases, complications, concomitant medications and concurrent treatments.	From start of study drug administration up to 7 days after the last dose (up to Day 16)
Secondary	Percentage of Participants With Clinically Significant Abnormal Change From Baseline to Post-Baseline in Vital Signs	Vital signs will include body temperature (oral or tympanic measurement), respiratory rate, blood pressure [systolic blood pressure (SBP) and diastolic blood pressure (DBP)] resting more than 5 minutes, and pulse (beats per minute). Data for participants with clinically significant abnormal vital signs will be reported.	Baseline to Day 10
Secondary	Percentage of Participants With Clinically Significant Abnormal Change From Baseline to Post-Baseline in 12-Lead Electrocardiograms (ECG)	ECGs will be performed with participants in a supine position. All ECG tracings will be reviewed by the Investigator or designee. Data for participants with clinically significant abnormal ECG values will be reported.	Baseline to Day 10
Secondary	Percentage of Participants With Clinically Significant Abnormal Change From Baseline to Post-Baseline in Laboratory Parameters	The percentage of participants with any clinically significant abnormal laboratory values (hematology, serum chemistry, and urinalysis) will be collected throughout study. Clinically significant abnormal values for hematology will include hematocrit (percentage of hematocrit [%]), hemoglobin (grams per liter [g/L]), erythrocyte mean corpuscular volume (MCV)(femtoliter [fL]), erythrocytes (10^12/L), and leukocytes (10^9/L). Clinically significant abnormal values for serum chemistry will include alanine aminotransferase (units per liter [U/L]), aspartate aminotransferase (U/L), cholesterol (millimoles per liter [mmol/L]), gamma glutamyl transferase (U/L), glucose (mmol/L): < 2.8 mmol/L, potassium (mmol/L), sodium (mmol/L), and triglycerides (mmol/L). ULN is upper limit of normal and LLN is lower limit of normal.	Baseline to Day 10
Secondary	Percentage of Participants With Clinically Significant Change From Baseline to Post-Baseline in Physical Examination	Physical examination will include the following body systems: (1) respiratory system; (2) cardiovascular system; (3) nervous system (4) dermatologic system; and (5) gastrointestinal system. A summarized data for the above body systems will be reported for participants with clinically significant findings.	Baseline to Day 10

External Links

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