Trial Outcomes & Findings for A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants (NCT NCT04501640)
NCT ID: NCT04501640
Last Updated: 2024-11-12
Results Overview
AUCinf for mirabegron was reported for the plasma samples collected.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period
Results posted on
2024-11-12
Participant Flow
Participants were enrolled at one site in China.
Healthy Chinese female and male participants between 18 to 45 years of age, inclusive (at screening), and met all of the inclusion and none of the exclusion criteria were eligible to participate in this study.
Participant milestones
| Measure |
Mirabegron 25 mg Fed/Mirabegron 25 mg Fasted
Participants received single dose of 25 milligrams (mg) mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
|
Mirabegron 25 mg Fasted/Mirabegron 25 mg Fed
Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
|
Mirabegron 50 mg Fed/Mirabegron 50 mg Fasted
Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
|
Mirabegron 50 mg Fasted/Mirabegron 50 mg Fed
Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
|
|---|---|---|---|---|
|
Period 1 (5 Days)
STARTED
|
6
|
6
|
6
|
6
|
|
Period 1 (5 Days)
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 1 (5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period (10 Days)
STARTED
|
6
|
6
|
6
|
6
|
|
Washout Period (10 Days)
COMPLETED
|
6
|
6
|
6
|
6
|
|
Washout Period (10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2 (5 Days)
STARTED
|
6
|
6
|
6
|
6
|
|
Period 2 (5 Days)
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 2 (5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants
Baseline characteristics by cohort
| Measure |
Mirabegron 25 mg Fed/Mirabegron 25 mg Fasted
n=6 Participants
Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
|
Mirabegron 25 mg Fasted/Mirabegron 25 mg Fed
n=6 Participants
Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
|
Mirabegron 50 mg Fed/Mirabegron 50 mg Fasted
n=6 Participants
Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
|
Mirabegron 50 mg Fasted/Mirabegron 50 mg Fed
n=6 Participants
Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.8 Years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
25.0 Years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
26.7 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
24.5 Years
STANDARD_DEVIATION 3.7 • n=4 Participants
|
26.0 Years
STANDARD_DEVIATION 5.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each periodPopulation: The pharmacokinetic analysis set (PKAS) consisted of all participants who received at least 1 dose of investigational product (IP) for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.
AUCinf for mirabegron was reported for the plasma samples collected.
Outcome measures
| Measure |
Mirabegron 25 mg Fed
n=12 Participants
Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 25 mg Fasted
n=12 Participants
Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 50 mg Fed
n=12 Participants
Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 50 mg Fasted
n=12 Participants
Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
|
|---|---|---|---|---|
|
Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron
|
81.8 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 37.2
|
143 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 39.3
|
263 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 26.9
|
429 Hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 36.8
|
PRIMARY outcome
Timeframe: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each periodPopulation: PKAS Population
AUClast for mirabegron was reported for the plasma samples collected.
Outcome measures
| Measure |
Mirabegron 25 mg Fed
n=12 Participants
Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 25 mg Fasted
n=12 Participants
Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 50 mg Fed
n=12 Participants
Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 50 mg Fasted
n=12 Participants
Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
|
|---|---|---|---|---|
|
Area Under The Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) For Mirabegron
|
63.3 h*ng/mL
Geometric Coefficient of Variation 36.8
|
119 h*ng/mL
Geometric Coefficient of Variation 40.8
|
218 h*ng/mL
Geometric Coefficient of Variation 25.4
|
369 h*ng/mL
Geometric Coefficient of Variation 39.5
|
PRIMARY outcome
Timeframe: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each periodPopulation: PKAS Population
Cmax for mirabegron was reported from the plasma samples collected.
Outcome measures
| Measure |
Mirabegron 25 mg Fed
n=12 Participants
Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 25 mg Fasted
n=12 Participants
Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 50 mg Fed
n=12 Participants
Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 50 mg Fasted
n=12 Participants
Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
|
|---|---|---|---|---|
|
Maximum Concentration (Cmax) For Mirabegron
|
3.07 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 29.9
|
7.88 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 82.1
|
15.9 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47.7
|
33.3 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 82.7
|
SECONDARY outcome
Timeframe: From date of informed consent signed to end of study (up to 24 days)Population: The safety analysis set (SAF) consisted of all participants who received at least 1 dose of study drug.
An AE is any untoward medical occurrence in a participant administered an study drug, and which does not necessarily have to have a causal relationship with this study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions results in congenital anomaly, or birth defect, requires inpatient hospitalization, other medically important AE. An AE with onset at any time from first dosing until last scheduled procedure was classified as a TEAE.
Outcome measures
| Measure |
Mirabegron 25 mg Fed
n=12 Participants
Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 25 mg Fasted
n=12 Participants
Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 50 mg Fed
n=12 Participants
Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 50 mg Fasted
n=12 Participants
Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE)
TEAE
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AE)
Drug-Related TEAE
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AE)
Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE)
Drug-Related Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE)
TEAE Leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE)
Drug-Related TEAE Leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE)
TEAE Leading to Withdrawal of Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE)
Drug-Related TEAE Leading to Withdrawal of Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE)
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Mirabegron 25 mg Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Mirabegron 25 mg Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Mirabegron 50 mg Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Mirabegron 50 mg Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mirabegron 25 mg Fed
n=12 participants at risk
Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 25 mg Fasted
n=12 participants at risk
Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 50 mg Fed
n=12 participants at risk
Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of either period 1 or period 2.
|
Mirabegron 50 mg Fasted
n=12 participants at risk
Participants received single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of either period 1 or period 2.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
8.3%
1/12 • Number of events 1 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
8.3%
1/12 • Number of events 1 • From date of informed consent signed to end of study (up to 24 days)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
8.3%
1/12 • Number of events 1 • From date of informed consent signed to end of study (up to 24 days)
|
|
Investigations
Blood uric acid increased
|
8.3%
1/12 • Number of events 1 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
|
Investigations
Protein urine present
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
8.3%
1/12 • Number of events 1 • From date of informed consent signed to end of study (up to 24 days)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
8.3%
1/12 • Number of events 1 • From date of informed consent signed to end of study (up to 24 days)
|
8.3%
1/12 • Number of events 1 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
8.3%
1/12 • Number of events 1 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
0.00%
0/12 • From date of informed consent signed to end of study (up to 24 days)
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma China, Inc.
Phone: +86-(0)10-85216666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER