A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants

NCT04501640 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 178-MA-2294CTR20201670
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study determined the effect of food on the pharmacokinetics (PK) of single oral doses of mirabegron in healthy Chinese male and female participants. This study also evaluated the safety and tolerability of single oral doses of mirabegron in healthy Chinese male and female participants.

Conditions

Pharmacokinetics of Mirabegron; Food Effect; Healthy Chinese Subjects

Keywords

mirabegron; pharmacokinetics; two-way crossover

Outcome Measures

Primary Outcomes (3)

• Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron

  AUCinf for mirabegron was reported for the plasma samples collected.

  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

• Area Under The Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) For Mirabegron

  AUClast for mirabegron was reported for the plasma samples collected.

  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

• Maximum Concentration (Cmax) For Mirabegron

  Cmax for mirabegron was reported from the plasma samples collected.

  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

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AE)

  From date of informed consent signed to end of study (up to 24 days)

Study Arms (4)

Mirabegron 25 mg fed/Mirabegron 25 mg fasted

EXPERIMENTAL

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 milligram (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.

Drug: mirabegron

Mirabegron 25 mg fasted/Mirabegron 25 mg fed

EXPERIMENTAL

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.

Drug: mirabegron

Mirabegron 50 mg fed/Mirabegron 50 mg fasted

EXPERIMENTAL

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.

Drug: mirabegron

Mirabegron 50 mg fasted/Mirabegron 50 mg fed

EXPERIMENTAL

Participants received single dose of 50 mg mirabegron 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.

Drug: mirabegron

Interventions

mirabegron DRUG

Oral adminstration

Also known as: Betmiga

Mirabegron 25 mg fasted/Mirabegron 25 mg fed; Mirabegron 25 mg fed/Mirabegron 25 mg fasted; Mirabegron 50 mg fasted/Mirabegron 50 mg fed; Mirabegron 50 mg fed/Mirabegron 50 mg fasted

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject has a body mass index range of 19.0 to 24.9 kg/m\^2, inclusive and weighs at least 50 kg for male subjects and 45 kg for female subjects at screening.
• Female subject is not pregnant and at least 1 of the following conditions apply:
• Not a woman of childbearing potential (WOCBP)
• WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final IP administration
• Female subject must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
• Female subject must not donate ova starting at first dose of IP and throughout the study period and for 30 days after final IP administration.
• Male subject with female partner(s) of childbearing potential (including breastfeeding partner\[s\]) must agree to use contraception throughout the study period and for 30 days after final IP administration.
• Male subject must not donate sperm during the study period and for 30 days after final IP administration.
• Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final IP administration.
• Subject agrees not to participate in another interventional study while participating in the present study, defined as 84 days prior screening until completion of the last study visit.

You may not qualify if:

• Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
• Subject has a known or suspected hypersensitivity to mirabegron or any components of the formulation used.
• Subject has had previous exposure with mirabegron.
• Subject has any of the liver function tests (alkaline phosphatase, alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma-glutamyl transferase and total bilirubin \[TBL\]) ≥ 1.5 × upper limit of normal (ULN) on day -1 of period 1.
• Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to first IP administration.
• Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
• Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1 of period 1.
• Subject has any of the following concerns with regard to tuberculosis:
• History of active tuberculosis
• Abnormalities detected in a chest X-ray on day -1 of period 1
• Contact with infectious tuberculous patients
• Subject has any clinically significant abnormality following the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1 of period 1.
• Participant has a mean pulse \< 45 bpm, \> 99 bpm; mean body temperature \< 35.0°C, \> 37.5°C; mean systolic blood pressure \< 90 mmHg, ≥ 140 mmHg; mean diastolic blood pressure \< 40 mmHg, ≥ 90 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes) at screening or on day-1 of period 1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
• Participant has a mean corrected QT interval using Fridericia's formula (QTcF) of: ≥ 430 msec (for male subjects) ≥ 450 msec (for female subjects) at screening or on day-1 of period 1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
• Subject has used any prescribed or nonprescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort and traditional Chinese medicine) in the 2 weeks prior to first IP administration, except for occasional use of paracetamol (up to 2 g/day), topical dermatological products, including corticosteroid products, hormonal contraceptives or hormone replacement therapy (HRT).

Sponsors & Collaborators

• Astellas Pharma China, Inc.: lead

Study Sites (1)

Site CN86001

Shanghai, China

Location

Related Links

• Link to results and other applicable study documents on the Astellas Clinical Trials website
• Link to plain language summary of the study on the Trial Results Summaries website

MeSH Terms

Interventions

mirabegron

Results Point of Contact

• Title: Clinical Trial Disclosure
• Organization: Astellas Pharma China, Inc.

astellas.resultsdisclosure@astellas.com

+86-(0)10-85216666

Study Officials

• Executive Director

  Astellas Pharma China, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open label study.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a two-way crossover design with 2 period and 2 dose groups. Participants were randomized to 1 of 4 sequences dependent on dose and period assigned.

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 6, 2020
• Study Start: September 21, 2020
• Primary Completion: October 14, 2020
• Study Completion: October 27, 2020
• Last Updated: November 12, 2024
• Results First Posted: October 29, 2021

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)