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

July 11, 2017 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom scores and secretion weights
Time Frame: up to 83 days
up to 83 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 31, 2009

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111611

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Study Protocol
    Information identifier: 111611
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: 111611
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: 111611
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annotated Case Report Form
    Information identifier: 111611
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: 111611
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: 111611
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistical Analysis Plan
    Information identifier: 111611
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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