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OpenTrials
Completed

NCT Number: NCT05818956

A Study of TAK-227 in Healthy Adults

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc.

Tempe, Arizona, 85283, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TAK-227

Drug

TAK-227 capsules.

Primary outcomes

  1. 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

  2. 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

  3. 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

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

    Time frame: From start of study drug administration up to 7 days after the last dose (up to Day 20)

    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.

  2. Number of Participants Based on Severity of TEAE

    Time frame: From start of study drug administration up to 7 days after the last dose (up to Day 20)

    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.

  3. Number of Participants Based on Causality of TEAEs

    Time frame: From start of study drug administration up to 7 days after the last dose (up to Day 20)

    Causality of TEAEs to the study medication was assessed using the following categories: Related: An AE that followed a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which a causal relationship was 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, might also be responsible; Not Related: An AE that did 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.

  4. Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values

    Time frame: Baseline to Day 13

    Vital signs included body temperature (oral or tympanic measurement), respiratory rate, blood pressure [systolic blood pressure (SBP) and diastolic blood pressure (DBP)], and pulse (beats per minute). The clinically significant change assessment was based on investigator's judgment. Number of participants with clinically significant change from baseline in vital signs values were reported.

  5. Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECG) Values

    Time frame: Baseline to Day 13

    ECGs was performed with participants in a supine position. All ECG tracings were reviewed by the investigator or designee. Number of participants with clinically significant change from baseline in ECG values were reported.

  6. Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters

    Time frame: Baseline to Day 13

    The clinically significant change assessment was based on investigator's judgment. Number of participants with clinically significant change from baseline in laboratory values (hematology, serum chemistry, and urinalysis) were reported.

  7. Number of Participants With Clinically Significant Change From Baseline in Physical Examination

    Time frame: Baseline to Day 13

    Physical examination included the following body systems: (1) respiratory system; (2) cardiovascular system; (3) nervous system (4) dermatologic system; and (5) gastrointestinal system. The clinically significant change assessment was based on investigator's judgment. Number of participants with clinically significant change from baseline in physical examination values were reported.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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