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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Rhinitis

Treatments: Other: Caspaicin; Drug: SB-705498; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00731250

111611

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 9 patient groups, including a placebo group

PART 1-Visit 1-Placebo

Placebo Comparator group

Description:

Eligible subjects will receive matching placebo tablets

Treatment:

Drug: Placebo

PART 1-Visit 1-Capsaicin

Experimental group

Description:

Eligible subjects will receive incremental capsaicin doses

Treatment:

Other: Caspaicin

PART 1-Visit 2-Placebo

Placebo Comparator group

Description:

Eligible subjects will receive matching placebo tablets

Treatment:

Drug: Placebo

PART 1-Visit 2-Capsaicin

Experimental group

Description:

Eligible subjects will receive maximum capsaicin dose

Treatment:

Other: Caspaicin

PART 1-Visit 3-Placebo

Placebo Comparator group

Description:

Eligible subjects will receive matching placebo tablets

Treatment:

Drug: Placebo

PART 1-Visit 3-Capsaicin

Experimental group

Description:

Eligible subjects will receive matching placebo tablets incremental capsaicin doses

Treatment:

Other: Caspaicin

PART 2-Visit 1-Placebo

Placebo Comparator group

Description:

Eligible subjects will receive matching placebo tablets

Treatment:

Drug: Placebo

PART 2-Visit 1-SB-705498

Experimental group

Description:

Eligible subjects will receive SB-705498 tablets

Treatment:

Drug: SB-705498

PART 2-Visit 2-Capsaicin

Experimental group

Description:

Eligible subjects will receive matching placebo tablets incremental capsaicin doses

Treatment:

Other: Caspaicin