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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteer; Rhinitis

Intervention: SB-705498 (Drug); Placebo (Drug); 0.5-5-50ug Caspaicin (Other); 50ug caspaicin (Other)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Symptom scores and secretion weights

Secondary outcome:

Peak nasal inspiratory flow changes after challenge

Biomarkers levels in the nasal samples

Blood levels of drug

Pharmacodynamic response

Safety parameters

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Amsterdam 1105 AZ, Netherlands
Additional Information

Starting date: July 2008
Last updated: May 19, 2011

Page last updated: August 20, 2015

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