Dose Proportionality Study: Blood Levels of Fluticasone Furoate (FF) and Vilanterol (VI) Following Different Doses of FF/VI Via an Inhaler

NCT01213849 | Completed Phase 1

• 1 other identifier: 102932
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI)following single dose administration of FF/VI via the novel dry powder inhaler in healthy subjects.

Conditions

Asthma

Outcome Measures

Primary Outcomes (4)

• Fluticasone furoate area under concentration-time curve (AUC)

  48 hours post-dose

• Fluticasone furoate maximum observed concentration (Cmax)

  48 hours post-dose

• Vilanterol area under concentration-time curve (AUC)

  48 hours post-dose

• Vilanterol maximum observed concentration (Cmax)

  48 hours post-dose

Secondary Outcomes (2)

• Fluticasone furoate time of occurence of maximum concentration (tmax)

  48 hours post-dose

• Vilanterol time of occurence of maximum concentration (tmax)

  48 hours post-dose

Study Arms (3)

200/100 mcg fluticasone furoate/vilanterol

EXPERIMENTAL

4 inhalations of 50/25 mcg fluticasone furoate/vilanterol

Drug: Fluticasone furoate 50 mcg (4 inhalations); Drug: Vilanterol 25 mcg (4 inhalations)

400/100 mcg fluticasone furoate/vilanterol

EXPERIMENTAL

4 inhalations of 100/25 mcg fluticasone furoate/vilanterol

Drug: Fluticasone furoate 100 mcg (4 inhalations); Drug: Vilanterol 25 mcg (4 inhalations)

800/100 mcg fluticasone furoate/vilanterol

EXPERIMENTAL

4 inhalations of 200/25 mcg fluticasone furoate/vilanterol

Drug: Fluticasone furoate 200 mcg (4 inhalations)

Interventions

Fluticasone furoate 50 mcg (4 inhalations) DRUG

4 inhalations of 50 mcg strength

200/100 mcg fluticasone furoate/vilanterol

Fluticasone furoate 100 mcg (4 inhalations) DRUG

4 inhalations of 100 mcg strength

400/100 mcg fluticasone furoate/vilanterol

Fluticasone furoate 200 mcg (4 inhalations) DRUG

4 inhalations of 200 mcg strength

800/100 mcg fluticasone furoate/vilanterol

Vilanterol 25 mcg (4 inhalations) DRUG

4 inhalations of 25 mcg strength

200/100 mcg fluticasone furoate/vilanterol; 400/100 mcg fluticasone furoate/vilanterol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT), alkaline phosphatase and bilirubin \<or= 1.5xULN
• Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
• Male or female between 18 and 65 years of age inclusive.
• A female subject is eligible to participate if she is of:
• Non-child-bearing potential defined as post-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea.
• Child-bearing potential and agrees to use one of the approved contraception methods until 16 weeks after the last dose.
• Male subjects with female partners of child-bearing potential must agree to use one of the approved contraception methods until 16 weeks after the last dose.
• Body Mass Index (BMI) within range 18.5-29.0 kg/m2 (inclusive).
• Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Average QTcF \< 450 msec.
• No clinically significant abnormality on the Holter electrocardiogram (ECG) at screening.
• Subjects who are current non-smokers, who have not used any tobacco products in the 12 month period preceding the screening visit, and have a pack history of \< or = 5 pack years.
• Able to satisfactorily use the dry powder inhaler.

You may not qualify if:

• As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age.
• The subject has a history of breathing problems in adult life (e.g. history of asthmatic symptomatology). Screening lung function tests (forced expiratory volume in 1 minute (FEV1)) will be performed to confirm normal lung function parameters (\>or=85% predicted).
• Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit.
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
• A positive HIV antibody.
• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
• History of heavy regular alcohol consumption within 6 months of the study defined as: an average weekly intake of \>21 units for males or \>14 units for females.
• History or regular use of tobacco- or nicotine-containing products within 12 months prior to screening.
• Positive carbon monoxide or alcohol breath test at screening or on admission to the unit.
• A positive pre-study urine drug screen or when randomly tested during the study.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
• The subject has taken systemic, oral or depot corticosteroids less than 12 weeks before the screening visit.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, NW10 7EW, United Kingdom

Location

Related Links

• Results for study 102932 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Interventions

fluticasone furoate; vilanterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: October 4, 2010
• Primary Completion: November 25, 2010
• Study Completion: November 25, 2010
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)