Phase 1
Completed N=20
A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults
Healthy Volunteers
Source: ClinicalTrials.gov NCT06268301 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Maximum Observed Concentration (Cmax) of BOS — 692.9; 604.1 picograms per milliliter (pg/mL)
Summary
The main aim of this study is to check what the body of a healthy adult who either fasted or had eaten does to TAK-721 and how TAK-721 is distributed in and removed from the body. Other aims are to learn how safe the treatment with TAK-721 is and how suitable the TAK-721 is for healthy adults who either fasted or had eaten. All participants will receive TAK-721 but half will be assigned by chance to the participant group who are fasting first then getting the high-fat/high-calorie meal later or the group who gets meal first and fasts later. The group assignment will be switched once during the course of the study so that all participants will receive TAK-721 in both a fasted or fed condition.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Concentration (Cmax) of BOS |
692.9; 604.1 | — |
| PRIMARY Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of BOS |
2811; 3529 | — |
| PRIMARY Area Under the Concentration-time Curve From Time 0 to Infinity (AUC∞) of BOS |
3075; 3892 | — |
| SECONDARY Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Events (SAE), and Death |
2; 5; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal Vital Sign Values Reported as Adverse Events |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values Reported as Adverse Events |
0; 0 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12) of BOS |
2728; 3208 | — |
| SECONDARY Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC∞ (AUCextrap%) of BOS |
7.275; 7.126 | — |
| SECONDARY Time to First Occurrence of Cmax (Tmax) of BOS |
1.286; 2.516 | — |
| SECONDARY Lag Time to First Quantifiable Concentration (Tlag) of BOS |
0.328; 0.308 | — |
| SECONDARY Terminal Disposition Phase Half-life (t1/2z) of BOS |
4.270; 5.096 | — |
| SECONDARY Terminal Disposition Phase Rate Constant (λz) of BOS |
0.1627; 0.1362 | — |
| SECONDARY Apparent Clearance (CL/F) of BOS Calculated Using the Observed Value of the Last Quantifiable Concentration of BOS |
650.4; 513.9 | — |
| SECONDARY Apparent Volume of Distribution During the Terminal Disposition Phase (Vz/F) of BOS Calculated Using the Observed Value of the Last Quantifiable Concentration of BOS |
3967; 3513 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meters squared (kg/m^2) at the screening visit.
Exclusion Criteria
- Presence of any active infection at the screening visit or check-in.
- Positive urine drug or alcohol results at the screening visit or check-in.
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
- Participant is unable to refrain from or anticipates the use of:
- Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing. Medication listed as part of acceptable birth control methods, hormone replacement therapy, and thyroid hormone replacement medication will be allowed.
- Any drugs known to be moderate or strong inducers of cytochrome P450 (CYP) 3A4 enzymes and/or p-glycoprotein (P-gp), including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of pharmacokinetic (PK) /pharmacodynamic interaction with the study drug.
- Participant is lactose intolerant.
- 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 (NCT06268301). 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.