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

NCT ID: NCT00731250

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-22
• Study Completion Date: 2009-03-31

Brief Summary

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

Conditions

Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PART 1-Visit 1-Placebo

Eligible subjects will receive matching placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will be administered SB-705498 matching placebo tablets

PART 1-Visit 1-Capsaicin

Eligible subjects will receive incremental capsaicin doses

Group Type: EXPERIMENTAL

Caspaicin

Intervention Type: OTHER

Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose

PART 1-Visit 2-Placebo

Eligible subjects will receive matching placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will be administered SB-705498 matching placebo tablets

PART 1-Visit 2-Capsaicin

Eligible subjects will receive maximum capsaicin dose

Group Type: EXPERIMENTAL

Caspaicin

Intervention Type: OTHER

Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose

PART 1-Visit 3-Placebo

Eligible subjects will receive matching placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will be administered SB-705498 matching placebo tablets

PART 1-Visit 3-Capsaicin

Eligible subjects will receive matching placebo tablets incremental capsaicin doses

Group Type: EXPERIMENTAL

Caspaicin

Intervention Type: OTHER

Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose

PART 2-Visit 1-Placebo

Eligible subjects will receive matching placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will be administered SB-705498 matching placebo tablets

PART 2-Visit 1-SB-705498

Eligible subjects will receive SB-705498 tablets

Group Type: EXPERIMENTAL

SB-705498

Intervention Type: DRUG

Subjects will be administered a single dose of 400 mg SB-705498

PART 2-Visit 2-Capsaicin

Eligible subjects will receive matching placebo tablets incremental capsaicin doses

Group Type: EXPERIMENTAL

Caspaicin

Intervention Type: OTHER

Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose

Interventions

SB-705498

Subjects will be administered a single dose of 400 mg SB-705498

Intervention Type: DRUG

Placebo

Subjects will be administered SB-705498 matching placebo tablets

Intervention Type: DRUG

Caspaicin

Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Amsterdam, , Netherlands

Countries

Netherlands

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

111611

Identifier Type: -

Identifier Source: org_study_id