Blood pressure, heart rate and energy expenditure effects of the drug mirabegron.

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12617000542392
• Date of registration: 18/04/2017
• Prospective Registration: No
• Primary sponsor: Baker Heart and Diabetes Institute
• Public title: Blood pressure, heart rate and energy expenditure effects of the drug mirabegron.
• Scientific title: Metabolic and cardiovascular responses to a beta-3 adrenergic receptor drug in healthy adults.
• Date of first enrolment: 03/04/2017
• Target sample size: 30
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617000542392.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Pharmacodynamics;

Countries of recruitment

Australia

Contacts

• Name: Dr Andrew Carey

• Name: Dr Andrew Carey

Key inclusion & exclusion criteria

Inclusion criteria: - Aged 18 – 40 years
- Not currently taking any prescription medications or other supplements or medications known to alter cardiovascular parameters or increase energy expenditure (as assessed by the study physician during medical screening)
- No history of major illness (as assessed by the study physician during medical screening)
- BMI equal to or less than 30 kg/m^2

Exclusion criteria: - Hypertension (resting supine blood pressure greater than 140/90 mmHg)
- Pregnancy


Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Obesity;
Obesity

Diet and Nutrition - Obesity

Metabolic and Endocrine - Metabolic disorders

Intervention(s)

This is a dose finding study to determine the dose response to increasing amounts of the beta-3 adrenergic receptor agonist mirabegron (outcome measurements listed subsequently).

Participants will be screened and given a medical assessment by a physician. If cleared for participation the physician will approve a prescription for participants to partake in the drug trials described below.

Participation will involve visiting the laboratory on 4 separate occasions, with each visit involving an oral dose of the drug mirabegron in a multiple ascending dose manner, each separated by between 3-14 days (based on participant availability). The 4 doses will be 50, 100, 150 and 200 mg.

Measurements of blood pressure, heart rate and energy expenditure (via indirect calorimetry) will be collected before and at 30 minute intervals after drug ingestion for 3 hours.

Primary Outcome(s)

Energy expenditure via indirect calorimetry[Energy expenditure will be assessed by measurement for 10 minutes before administering the drug dose, then for 10 minutes, every 30 minutes (eg, from 20-30 min, 50-60 min, 80-90 min, and so on) until 3 hours (from 170-180 minutes) post dosing. While multiple measurements will be obtained, the primary endpoint comparison will be between pre-drug ingestion and 3 hours post ingestion.]

Secondary Outcome(s)

heart rate via an automated sphygmomanometer[Heart rate will be assessed by measurement before administering the drug dose, then every 30 minutes post dosing for 3 hours. Each individual measurement will take approximately 30 seconds. While multiple measurements will be obtained, the primary endpoint comparison will be between pre-drug ingestion and 3 hours post ingestion. ]

Blood pressure via an automated sphygmomanometer[Blood pressure will be assessed by measurement before administering the drug dose, then every 30 minutes post dosing for 3 hours. Each individual measurement will take approximately 30 seconds. While multiple measurements will be obtained, the primary endpoint comparison will be between pre-drug ingestion and 3 hours post ingestion.]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Baker Heart and Diabetes Institute

Ethics review

Status: Approved
Approval date:
Contact:

Alfred Hospital Human Ethics Committee