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A Study to Investigate the Effect of SB-705498 on Chronic Cough

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Cough

Intervention: Placebo (Drug); SB-705498 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

This study is designed to loook at the affect of oral SB-705498 on cough following an inhaled capsaicin challenge

Clinical Details

Official title: Two Part Study to Investigate Pharmacokinetics (PK) & Pharamcodynamics (PD) of SB-705498 in Cough. Part A:Open Label Study in Healthy Subjects to Determine Exposure to SB-705498. Part B:Double-blind, Placebo Controlled, Cross Over Study to Investigate Effect of SB-705498 on Capsaicin Induced Cough and 24 Hour Cough Counts in Cough Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Blood levels of drug

capsaicin concentration required to achieve C5

24 hour cough count

Secondary outcome:

capsaicin concentration required to reach C2

safety parameters

changes in CQLQ

VAS scale

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female between 30 -75 (Part A) and 18-75 (Part B) years of age inclusive.

- Non-child bearing women or women of child bearing potential if they agree to use

contraception as indicated by the protocol

- Non-smoker for at least 6 months with a pack history <5 pack years (Pack years = (No.

of cigarettes smoked/day/20) x No. of years smoked).

- Body weight > 50 kg and body mass index (BMI) within the range 19 - 30. 0 kg/m2

(inclusive).

- Capable of giving written informed consent.

- Agree to use contraception listed as acceptable

- Normal 12-lead ECG at screening.

- Chronic cough (Part B only)

- Good general health, apart from chronic cough (part B only), as determined by a

responsible physician. Exclusion Criteria:

- A history of gastrointestinal, hepatic, renal or multiple cardiovascular risk

factors.

- Positive pre-study drug/alcohol screen.

- Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody

result within 3 months of screening.

- A positive test for human immunodeficiency virus (HIV) antibody (if determined by the

local standard operating procedures (SOPs)).

- History of regular alcohol consumption within 6 months of the study.

- Exposure to more than four new chemical entities within 12 months prior to the start

of the study.

- Participation in a clinical trial with a new molecule entity or any other clinical

trial within 30 days of the start of the study.

- Use of prescription or non-prescription drugs, as well as of vitamins, herbal and

dietary supplements (including St John's Wort) within 7 days prior to study.

- known history of lung cancer

- current treatment with oral corticosteriods or other immunosupressive agents

- FEV1 less than 80% of predicted value at screening

- Any subject who does not reach C5 following 250uM oral capsaicin

- History of drug or other allergy that, in the opinion of the Investigator or GSK

Medical Monitor, contraindicates their participation.

- Donation of blood or blood products in excess of 500mL within a 56 day period prior

the start study.

- Pregnant females as determined by positive serum or urine human chorionic

gonadotropin (hCG) test at screening or prior to dosing.

- Lactating females.

- Unwillingness or inability to follow the procedures outlined in the protocol.

- Cotinine levels indicative of smoking or history or regular use of tobacco- or

nicotine-containing products within 6 months prior to screening.

- consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days

prior to dosing.

Locations and Contacts

GSK Investigational Site, Manchester M23 9QZ, United Kingdom
Additional Information

Starting date: April 2011
Last updated: January 26, 2012

Page last updated: August 20, 2015

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