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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00731250
First received: August 5, 2008
Last updated: May 19, 2011
Last verified: February 2011
  Purpose

This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge


Condition Intervention Phase
Healthy Volunteer
Rhinitis
Drug: SB-705498
Drug: Placebo
Other: 0.5-5-50ug Caspaicin
Other: 50ug caspaicin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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: Various timepoints ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Peak nasal inspiratory flow changes after challenge [ Time Frame: Various timepoints ] [ Designated as safety issue: Yes ]
  • Biomarkers levels in the nasal samples [ Time Frame: Various timepoints ] [ Designated as safety issue: No ]
  • Blood levels of drug [ Time Frame: Various timepoints ] [ Designated as safety issue: No ]
  • Pharmacodynamic response [ Time Frame: Various timepoints ] [ Designated as safety issue: No ]
  • Safety parameters [ Time Frame: Various timepoints ] [ Designated as safety issue: Yes ]

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
Active Comparator: Part 2 - Arm 1
SD SB-705498 or placebo
Drug: SB-705498
400mg oral SB-705498
Drug: Placebo
SB-705498 placebo
Experimental: Part 1 - Arm 1
3 incremental capsaicin doses
Other: 0.5-5-50ug Caspaicin
3 doses capsaicin challenge
Experimental: Part 1 - Arm 2
Single dose capsaicin
Other: 50ug caspaicin
SD 50ug capsacin
Experimental: Part 1 - Arm 3
3 incremental capsaicin doses
Other: 0.5-5-50ug Caspaicin
3 doses capsaicin challenge
Experimental: Part 2 - Arm 2
3 incremental capsaicin doses
Other: 0.5-5-50ug Caspaicin
3 doses capsaicin challenge
Active Comparator: Part 2 - Arm 3
SD SB-705498 or placebo
Drug: SB-705498
400mg oral SB-705498
Drug: Placebo
SB-705498 placebo
Experimental: Part 2 - Arm 4
3 incremental capsaicin doses
Other: 0.5-5-50ug Caspaicin
3 doses capsaicin challenge

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00731250     History of Changes
Other Study ID Numbers: 111611
Study First Received: August 5, 2008
Last Updated: May 19, 2011
Health Authority: Netherlands: De Centrale Commissie Mensgebonden Onderzoek

Keywords provided by GlaxoSmithKline:
Capsaicin challenge

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

ClinicalTrials.gov processed this record on July 22, 2014