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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01476098
First received: October 13, 2011
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Chronic Cough
Drug: Placebo
Drug: SB-705498
Phase 2

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Blood levels of drug [ Time Frame: up to 10 hours post dose ] [ Designated as safety issue: Yes ]
  • capsaicin concentration required to achieve C5 [ Time Frame: post dose ] [ Designated as safety issue: No ]
  • 24 hour cough count [ Time Frame: various ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • capsaicin concentration required to reach C2 [ Time Frame: post dose ] [ Designated as safety issue: No ]
  • safety parameters [ Time Frame: various ] [ Designated as safety issue: Yes ]
  • changes in CQLQ [ Time Frame: various ] [ Designated as safety issue: No ]
  • VAS scale [ Time Frame: various ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: April 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
incremental doses capsaicin
Drug: Placebo
SB-705498 placebo
Drug: SB-705498
400 or 600mg oral SB-705498
Active Comparator: Arm 2
incremenrtal doses casaicin
Drug: Placebo
SB-705498 placebo
Drug: SB-705498
400 or 600mg oral SB-705498

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476098

Locations
United Kingdom
GSK Investigational Site
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01476098     History of Changes
Other Study ID Numbers: 114693
Study First Received: October 13, 2011
Last Updated: January 26, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014