Phase 1
Completed N=24
A Study of TAK-227 in Healthy Adults
Healthy Volunteers
Source: ClinicalTrials.gov NCT05818956 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for TAK-227 — 464.4; 190.9; 370.0 nanogram per milliliter (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for TAK-227 |
464.4; 190.9; 370.0 | — |
| PRIMARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-227 |
1582; 969.2; 1056 | — |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-227 |
1708; 983.7; 1070 | — |
| SECONDARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs |
4; 5; 2; 0; 0; 0 | — |
| SECONDARY Number of Participants Based on Severity of TEAE |
3; 5; 2; 1; 0; 0 | — |
| SECONDARY Number of Participants Based on Causality of TEAEs |
3; 3; 2; 1; 2; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECG) Values |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Physical Examination |
0; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05818956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.