Investigating The Pharmacokinetics Of An Inhaled Dose Of A New Corticosteroid In Patients With Impaired Liver Function

NCT00419237 | Completed Phase 1

• 1 other identifier: FFA10013
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The proposed study is designed to investigate the pharmacokinetics, pharmacodynamics (as measured by serum cortisol) and safety of GW685698X in subjects with moderate hepatic impairment and in healthy subjects following a single oral inhaled dose of GW685698X. From the study results it should be possible to assess if there is an altered Risk: Benefit in patients with moderate hepatic impairment

Conditions

Asthma

Keywords

hepatic impairment pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• To investigate how impaired liver function affects the movement of single dose inhaled drug GW685698X within the body. Blood exposure levels in patients and matched control patients compared by taking blood samples after dosing

  Up to Day 13

Secondary Outcomes (1)

• Effect of GW685698X on serum cortisol by calculating weighted mean in blood over 24 hrs. Safety and tolerability of GW685698X in patients with impaired liver function from blood samples during dosing (clearance/distribution) and monitoring vital signs

  Up to Day 13

Study Arms (2)

Healthy subjects

ACTIVE COMPARATOR

Subjects with normal liver function test will be administered a single oral inhaled dose of 400 micrograms (mcg) GW685698X in the morning of the study day. Each healthy subject will be matched as closely as possible for age, gender, bodyweight and race to a subject with impaired liver function.

Drug: GW685698X

Subjects with hepatic impairment

EXPERIMENTAL

Subjects with Child Pugh B hepatic dysfunction will be administered a single oral inhaled dose of 400 mcg GW685698X in the morning of the study day.

Drug: GW685698X

Interventions

GW685698X DRUG

GW685698X will be available as dry white powder to be inhaled via DISKUS containing cellobiose octaacetate (COA) blended with lactose.

Healthy subjects; Subjects with hepatic impairment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are aged between 18-70 years, inclusive.
• If Female, you must be incapable of becoming pregnant.
• Show FEV1 of more than 70% of the predicted normal at screening.
• Are able to correctly use a DISKUS at the screening visit.
• Have Body Mass Index within the range of 19-33 kg/m2 inclusive.
• Do not show a positive pre-study urine drug screen.
• Do not show a positive pre-study blood alcohol test.
• Demonstrate a clinically normal 12-lead ECG at screening.
• Do not show a positive blood test for HIV.
• If you are a Healthy Volunteer you must also:
• Have no significant abnormality on clinical examination.
• Have Liver Function Tests within the reference range at screening.
• If you are a Patient Volunteer you must:
• Have moderate hepatic impairment
• Have no significant abnormality on clinical examination apart from hepatic impairment.

You may not qualify if:

• Suffered an upper respiratory infection in the 4 weeks before the screening visit.
• Suffered a lower respiratory infection in the 6 weeks before the screening visit.
• Taken oral corticosteroids in the 8 weeks before the screening visit.
• Taken inhaled, intranasal or topical steroids in the 4 weeks before the screening visit.
• A prolonged heartbeat (QTc interval \>470msec).
• High blood pressure (systolic \>160mmHg or diastolic \>90mmHg) or as defined by the Investigator.
• Known sensitivity to corticosteroids.
• A history of lactose intolerance.
• A history of severe milk protein allergy.
• Donated blood in the last 3 months, or more than 1500mL (1000mL if female) in the last 12 months (including the amount taken for this study).
• Participated in a clinical trial within the last 3 months where you are/were exposed to a drug or device.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study FFA10013 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Asthma

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2007
• First Posted: January 8, 2007
• Study Start: January 13, 2005
• Primary Completion: April 15, 2005
• Study Completion: April 15, 2005
• Last Updated: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share