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A Study To Assess The Effect Of SB-705498 In A Capsaicin Challenge Model

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00731250
First received: August 5, 2008
Last updated: March 13, 2017
Last verified: March 2017
  Purpose
This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge

Condition Intervention Phase
Rhinitis Drug: SB-705498 Drug: Placebo Other: Caspaicin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study to Assess the Effect of Oral, Single Dose SB-705498 in a Validated Intranasal Capsaicin Challenge Model in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Symptom scores and secretion weights [ Time Frame: up to 83 days ]

Secondary Outcome Measures:
  • Peak nasal inspiratory flow changes after challenge [ Time Frame: up to 83 days ]
  • Biomarkers levels in the nasal samples [ Time Frame: up to 83 days ]
  • Blood levels of drug [ Time Frame: up to 83 days ]
  • Pharmacodynamic response [ Time Frame: up to 83 days ]
  • Safety parameters [ Time Frame: up to 83 days ]

Enrollment: 45
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PART 1-Visit 1-Placebo
Eligible subjects will receive matching placebo tablets
Drug: Placebo
Subjects will be administered SB-705498 matching placebo tablets
Experimental: PART 1-Visit 1-Capsaicin
Eligible subjects will receive incremental capsaicin doses
Other: Caspaicin
Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose
Placebo Comparator: PART 1-Visit 2-Placebo
Eligible subjects will receive matching placebo tablets
Drug: Placebo
Subjects will be administered SB-705498 matching placebo tablets
Experimental: PART 1-Visit 2-Capsaicin
Eligible subjects will receive maximum capsaicin dose
Other: Caspaicin
Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose
Placebo Comparator: PART 1-Visit 3-Placebo
Eligible subjects will receive matching placebo tablets
Drug: Placebo
Subjects will be administered SB-705498 matching placebo tablets
Experimental: PART 1-Visit 3-Capsaicin
Eligible subjects will receive matching placebo tablets incremental capsaicin doses
Other: Caspaicin
Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose
Placebo Comparator: PART 2-Visit 1-Placebo
Eligible subjects will receive matching placebo tablets
Drug: Placebo
Subjects will be administered SB-705498 matching placebo tablets
Experimental: PART 2-Visit 1-SB-705498
Eligible subjects will receive SB-705498 tablets
Drug: SB-705498
Subjects will be administered a single dose of 400 mg SB-705498
Experimental: PART 2-Visit 2-Capsaicin
Eligible subjects will receive matching placebo tablets incremental capsaicin doses
Other: Caspaicin
Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy.
  • Male or female between 18 and 60 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 - 29.9 kg/m2 (inclusive).
  • Capable of giving written informed consent.
  • Available to complete all the required study measurements.
  • Normal 12-lead ECG at screening.
  • For Part 2 only: The subject must demonstrate reactivity to unilateral, intranasal challenge with the selected single dose of capsaicin, defined as development of TSS ≥ 3.

Exclusion Criteria:

  • Past medical history of rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis.
  • Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations.
  • 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 4 months 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 2 days prior to each study visit in Part 1 of the study or 14 days prior to the first treatment administration in Part 2 of the study.
  • Inability to abstain from all intranasal or oral medication to treat nasal symptoms from the first capsaicin challenge to the completion of the study including: sodium cromoglycate, antihistamines, anticholinergics, alpha-adrenergic agonists and corticosteroids
  • History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
  • Subjects demonstrating hypersensitivity to the placebo capsaicin challenge at baseline screening.
  • Donation of blood or blood products in excess of 500mL within a 56 day period prior the start of Part 2 of this 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.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Nicotine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
  • For Part 2 only: Subjects with known lactose intolerance.
  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: NCT00731250

Locations
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 111611
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 111611
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 111611
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 111611
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 111611
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 111611
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 111611
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00731250     History of Changes
Other Study ID Numbers: 111611
Study First Received: August 5, 2008
Last Updated: March 13, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Capsaicin challenge

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017