Trial Outcomes & Findings for A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults (NCT NCT06268301)
NCT ID: NCT06268301
Last Updated: 2024-12-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
Results posted on
2024-12-02
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 6 February 2023 to 20 February 2023.
Healthy participants were enrolled to receive budesonide oral suspension (BOS) in either of the 2 treatment sequences Fasted-Fed or Fed-Fasted.
Participant milestones
| Measure |
Sequence 1: BOS 2 mg Fasted, Then Fed
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 under fasted condition (Treatment A). After a washout of at least 2 days participants then received 2 mg BOS single dose, orally on Day 1 of Period 2 under fed condition (Treatment B).
|
Sequence 2: BOS 2 mg Fed, Then Fasted
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 under fed condition (Treatment B). After a washout of at least 2 days participants received 2 mg BOS single dose, orally on Day 1 of Period 2 under fasted condition (Treatment A).
|
|---|---|---|
|
Period 1
STARTED
|
10
|
10
|
|
Period 1
COMPLETED
|
10
|
10
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
10
|
10
|
|
Period 2
COMPLETED
|
10
|
10
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults
Baseline characteristics by cohort
| Measure |
Sequence 1: BOS 2 mg Fasted, Then Fed
n=10 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 under fasted condition (Treatment A). After a washout of at least 2 days participants then received 2 mg BOS single dose, orally on Day 1 of Period 2 under fed condition (Treatment B).
|
Sequence 2: BOS 2 mg Fed, Then Fasted
n=10 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 under fed condition (Treatment B). After a washout of at least 2 days participants received 2 mg BOS single dose, orally on Day 1 of Period 2 under fasted condition (Treatment A).
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
32.7 years
STANDARD_DEVIATION 9.97 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 9.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.52 kilograms per metre square (kg/m^2)
STANDARD_DEVIATION 2.910 • n=5 Participants
|
27.59 kilograms per metre square (kg/m^2)
STANDARD_DEVIATION 2.706 • n=7 Participants
|
27.56 kilograms per metre square (kg/m^2)
STANDARD_DEVIATION 2.735 • n=5 Participants
|
|
Height
|
165.4 centimetres (cm)
STANDARD_DEVIATION 10.71 • n=5 Participants
|
169.0 centimetres (cm)
STANDARD_DEVIATION 11.52 • n=7 Participants
|
167.2 centimetres (cm)
STANDARD_DEVIATION 10.98 • n=5 Participants
|
|
Weight
|
75.99 kilograms (kg)
STANDARD_DEVIATION 15.39 • n=5 Participants
|
79.51 kilograms (kg)
STANDARD_DEVIATION 14.53 • n=7 Participants
|
77.75 kilograms (kg)
STANDARD_DEVIATION 14.68 • n=5 Participants
|
PRIMARY outcome
Timeframe: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1Population: Pharmacokinetic (PK) Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Maximum Observed Concentration (Cmax) of BOS
|
692.9 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 54.4
|
604.1 picograms per milliliter (pg/mL)
Geometric Coefficient of Variation 46.6
|
PRIMARY outcome
Timeframe: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of BOS
|
2811 picograms*hours per milliliter (pg*h/mL)
Geometric Coefficient of Variation 57.5
|
3529 picograms*hours per milliliter (pg*h/mL)
Geometric Coefficient of Variation 52.1
|
PRIMARY outcome
Timeframe: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC∞) of BOS
|
3075 pg*h/mL
Geometric Coefficient of Variation 57.0
|
3892 pg*h/mL
Geometric Coefficient of Variation 47.1
|
SECONDARY outcome
Timeframe: From first dose of study drug up to the end of study (EOS) (Up to 15 days)Population: Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug. An SAE was defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that may require an intervention to prevent above items and expose the participant to danger.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Events (SAE), and Death
TEAEs
|
2 Participants
|
5 Participants
|
|
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Events (SAE), and Death
SAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Events (SAE), and Death
Deaths
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to EOS (Up to 15 days)Population: Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
Vital signs included body temperature, respiratory rate, blood pressure, and pulse rate evaluations.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Vital Sign Values Reported as Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to EOS (Up to 15 days)Population: Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
Clinical laboratory parameters included hematology, clinical chemistry, serum immunoglobulin and urinalysis tests.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values Reported as Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 12 hours) post-dose on Day 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12) of BOS
|
2728 pg*h/mL
Geometric Coefficient of Variation 53.0
|
3208 pg*h/mL
Geometric Coefficient of Variation 42.2
|
SECONDARY outcome
Timeframe: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC∞ (AUCextrap%) of BOS
|
7.275 percentage of AUC
Geometric Coefficient of Variation 61.7
|
7.126 percentage of AUC
Geometric Coefficient of Variation 75.6
|
SECONDARY outcome
Timeframe: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Time to First Occurrence of Cmax (Tmax) of BOS
|
1.286 hours (h)
Interval 0.55 to 2.57
|
2.516 hours (h)
Interval 1.01 to 6.03
|
SECONDARY outcome
Timeframe: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Lag Time to First Quantifiable Concentration (Tlag) of BOS
|
0.328 hours
Interval 0.26 to 0.56
|
0.308 hours
Interval 0.25 to 0.53
|
SECONDARY outcome
Timeframe: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Terminal Disposition Phase Half-life (t1/2z) of BOS
|
4.270 hours
Interval 2.13 to 6.98
|
5.096 hours
Interval 2.78 to 7.35
|
SECONDARY outcome
Timeframe: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Terminal Disposition Phase Rate Constant (λz) of BOS
|
0.1627 1/hour
Interval 0.0994 to 0.325
|
0.1362 1/hour
Interval 0.0943 to 0.249
|
SECONDARY outcome
Timeframe: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Apparent Clearance (CL/F) of BOS Calculated Using the Observed Value of the Last Quantifiable Concentration of BOS
|
650.4 liters per hour (L/h)
Geometric Coefficient of Variation 57.0
|
513.9 liters per hour (L/h)
Geometric Coefficient of Variation 47.1
|
SECONDARY outcome
Timeframe: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 Participants
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
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 liters (L)
Geometric Coefficient of Variation 45.0
|
3513 liters (L)
Geometric Coefficient of Variation 32.9
|
Adverse Events
Treatment A: BOS 2 mg Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment B: BOS 2 mg Fed
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: BOS 2 mg Fasted
n=20 participants at risk
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition.
|
Treatment B: BOS 2 mg Fed
n=20 participants at risk
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition.
|
|---|---|---|
|
Nervous system disorders
Headache
|
10.0%
2/20 • From first dose of study drug up to the EOS (15 days)
Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
|
5.0%
1/20 • From first dose of study drug up to the EOS (15 days)
Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/20 • From first dose of study drug up to the EOS (15 days)
Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
|
5.0%
1/20 • From first dose of study drug up to the EOS (15 days)
Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/20 • From first dose of study drug up to the EOS (15 days)
Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
|
5.0%
1/20 • From first dose of study drug up to the EOS (15 days)
Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.0%
1/20 • From first dose of study drug up to the EOS (15 days)
Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
|
0.00%
0/20 • From first dose of study drug up to the EOS (15 days)
Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • From first dose of study drug up to the EOS (15 days)
Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
|
5.0%
1/20 • From first dose of study drug up to the EOS (15 days)
Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/20 • From first dose of study drug up to the EOS (15 days)
Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
|
10.0%
2/20 • From first dose of study drug up to the EOS (15 days)
Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER