A Randomized Study Evaluating Steroid Hormone Levels, Safety And Tolerability Of GW870086X In Healthy Volunteers

Asthma Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Dose Ascending, 3-cohort Parallel Group Study to Measure the Systemic Cortisol Profile and Evaluate the Safety, Tolerability and Pharmacokinetics of GW870086X, Administered as Single Doses (12mg and 15mg), and Repeat Doses Over 3 Days (6mg, 12mg and 15mg) in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549497
• Other study ID #: SIG110405
• Status: Completed
• Phase: Phase 1
• First received: October 24, 2007
• Last updated: February 2, 2017
• Start date: September 2007
• Est. completion date: January 2008

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

GW870086X is a novel inhaled steroid that has an improved safety profile over other steroids but is also less potent. This study will look at higher doses to confirm the improved safety profile.

Description:

A randomized, double-blind, placebo-controlled, dose ascending, 3-cohort parallel group study to measure the systemic cortisol profile and evaluate the safety, tolerability and pharmacokinetics of GW870086X, administered as single doses (12mg and 15mg),and repeat doses over 3 days (6mg, 12mg and 15mg) in healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria:

• Healthy male subjects

• Liver function tests normal

• 18 - 45 years old

• Non smoker

• Can provide written informed consent

• Available to complete the whole trial

• Can use the inhalation device correctly

• Able to read, understand and write English

Exclusion criteria:

• Deemed suitable healthy subject

• History to sensitivity to the study medication

• Any history of breathing problems in adult life

• Participated in another trial within 30 days or 5 half-lives of the new chemical entity

• Exposed to more than 4 new chemical entities within 12 months

• Donated >500 mL blood within 2 months of screening

• Haemoglobin level < 13g/dl

• Use of prescription or non-prescription drugs within 7 days of first dose

• Taking drugs that significantly inhibit cytochrome P450 subfamily enzyme CYP3A4

• Drinks more than 4 units a day or 28 units a week

• Cannot use DISKHALER device correctly

• Positive HepB, HepC within 3 months of screening

• Positive HIV test

• Positive pre study drug/alcohol screen

• Significant cardiac conduction abnormalities

• Risk of non-compliance

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• GW870086X

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Herston	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of GW870086X on cortisol levels (naturally produced steroid hormone) in the body during a single dose and after 3 days of dosing		3 days
Secondary	Safety & tolerability measures: heart rate, blood pressure, ECG, safety laboratory tests, lung function		3 days
Secondary	Total urinary free cortisol excretion		over 24 hours on Day 1 and Day 3.
Secondary	Serum osteocalcin weighted mean		over 24 hours on Day 3.
Secondary	Fasting glucose		on Day 1
Secondary	mRNA steroid responsive gene panel		3 days
Secondary	Plasma concentrations of GW870086X and GW870086X pharmacokinetic parameters (including AUC, Cmax, t1/2 and tmax).		3 days
Secondary	Plasma concentrations of GW870086X and derived pharmacokinetic parameters		3 days
Secondary	Cortsiol urine concentrations		3 days
Secondary	Osteocalcin serum concentrations		3 days