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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014