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

NCT00731250 | Completed Phase 1

• 1 other identifier: 111611
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rhinitis

Keywords

Capsaicin challenge

Outcome Measures

Primary Outcomes (1)

• Symptom scores and secretion weights

  up to 83 days

Secondary Outcomes (5)

• Peak nasal inspiratory flow changes after challenge

  up to 83 days

• Biomarkers levels in the nasal samples

  up to 83 days

• Blood levels of drug

  up to 83 days

• Pharmacodynamic response

  up to 83 days

• Safety parameters

  up to 83 days

Study Arms (9)

PART 1-Visit 1-Placebo

PLACEBO COMPARATOR

Eligible subjects will receive matching placebo tablets

Drug: Placebo

PART 1-Visit 1-Capsaicin

EXPERIMENTAL

Eligible subjects will receive incremental capsaicin doses

Other: Caspaicin

PART 1-Visit 2-Placebo

PLACEBO COMPARATOR

Eligible subjects will receive matching placebo tablets

Drug: Placebo

PART 1-Visit 2-Capsaicin

EXPERIMENTAL

Eligible subjects will receive maximum capsaicin dose

Other: Caspaicin

PART 1-Visit 3-Placebo

PLACEBO COMPARATOR

Eligible subjects will receive matching placebo tablets

Drug: Placebo

PART 1-Visit 3-Capsaicin

EXPERIMENTAL

Eligible subjects will receive matching placebo tablets incremental capsaicin doses

Other: Caspaicin

PART 2-Visit 1-Placebo

PLACEBO COMPARATOR

Eligible subjects will receive matching placebo tablets

Drug: Placebo

PART 2-Visit 1-SB-705498

EXPERIMENTAL

Eligible subjects will receive SB-705498 tablets

Drug: SB-705498

PART 2-Visit 2-Capsaicin

EXPERIMENTAL

Eligible subjects will receive matching placebo tablets incremental capsaicin doses

Other: Caspaicin

Interventions

SB-705498 DRUG

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

PART 2-Visit 1-SB-705498

Placebo DRUG

Subjects will be administered SB-705498 matching placebo tablets

PART 1-Visit 1-Placebo; PART 1-Visit 2-Placebo; PART 1-Visit 3-Placebo; PART 2-Visit 1-Placebo

Caspaicin OTHER

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

PART 1-Visit 1-Capsaicin; PART 1-Visit 2-Capsaicin; PART 1-Visit 3-Capsaicin; PART 2-Visit 2-Capsaicin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Amsterdam, 1105 AZ, Netherlands

Location

Related Links

• Results for study 111611 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Rhinitis

Interventions

SB 705498

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 8, 2008
• Study Start: July 22, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 31, 2009
• Last Updated: July 13, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)