rine concentrations of vilanterol after inhaled administration of vilanterol/fluticasone furoate: Defining a urine threshold and decision limit for vilanterol in doping control analysis

Phase 1

• Conditions: Pharmacokinetics of vilanterol in relation to doping analysis; MedDRA version: 21.0Level: LLTClassification code 10053349Term: Pharmacokinetic studySystem Organ Class: 100000004848; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2018-002529-48-DK
• Lead Sponsor: Center for Aktiv Sundhed, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-03
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Included subjects are:
- Healthy
- 18 - 39 years
- Able to use an inhalation device
- Active at least 5 hours a week
- VO2-max classified as high or very high measured during incremental test to exhaustion during the screening visit
- Male or non-pregnant female
- Females of childbearing potential has to use one or more methods for contraception in order to be included: vasectomised partner, bilateral tubal occlusion, sexual abstinence, intrauterine device or hormonal contraception.
- Females who are considered to have no childbearing potential are: bilateral tubal ligation, bilateral oophorectomy, complete hysterectomy, postmenopausal defined as 12 months with no menses without an alternative Medical cause.
- Non-smokers
- No daily use of prescribed medicine
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Diagnosis of Heart, pulmonary (including asthma GINA 2-5), intestinal and renal diseases
- Allergy towards active drug or any substances used in the drug
- Non-compliance with the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine urine concenctrations of vilanterol and its metabolites after therapeutic and supratherapeutic use. ;Secondary Objective: To determine urine concentrations of vilanterol and its metabolites after 7 days of therapeutic and supratherapeutic use. ;Primary end point(s): Urineconcentration of vilanterol and its metabolites (GSK932009 and GW630200) after inhalation of Relvar. ;Timepoint(s) of evaluation of this end point: Endpoints will be evaluated last part of 2018

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable