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A Study to Evaluate the Effect of Gefapixant (AF-219/MK-7264) on Methacholine Hyper-reactivity in Subjects With Asthma

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ClinicalTrials.gov Identifier: NCT01993329
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.

Brief Summary:
This is a randomised, double blind, double-dummy, placebo-controlled, three way crossover, single centre study in subjects with asthma undergoing inhalation of methacholine and ATP to assess the PC20 response of two dose levels of gefapixant (AF-219) compared with placebo.

Condition or disease Intervention/treatment Phase
Asthma Drug: Gefapixant 50 mg Drug: Gefapixant 300 mg Drug: Placebo (for AF219) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Way Cross-over Study to Evaluate the Effect of AF-219 on Methacholine Hyper-reactivity in Subjects With Asthma
Actual Study Start Date : December 31, 2013
Actual Primary Completion Date : February 28, 2014
Actual Study Completion Date : February 28, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Gefapixant and placebo
Gefapixant 50 mg tablet and placebo (for gefapixant) tablet by mouth twice daily for 3.5 days
Drug: Gefapixant 50 mg
Other Names:
  • AF-219
  • MK-7264

Drug: Placebo (for AF219)
sugar pill manufactured to mimic gefapixant 50 mg and 300 mg tablets

Placebo Comparator: Placebo
Placebo (for gefapixant) tablets by mouth twice daily for 3.5 days
Drug: Placebo (for AF219)
sugar pill manufactured to mimic gefapixant 50 mg and 300 mg tablets

Experimental: Gefapixant 300 mg and placebo
Gefapixant 300 mg tablet and placebo (for gefapixant) tablet by mouth twice daily for 3.5 days
Drug: Gefapixant 300 mg
Other Names:
  • AF-219
  • MK-7264

Drug: Placebo (for AF219)
sugar pill manufactured to mimic gefapixant 50 mg and 300 mg tablets




Primary Outcome Measures :
  1. PC20 response of two dose levels of gefapixant compared with placebo in subjects with asthma after provocation with methacholine [ Time Frame: 3.5 days ]

Secondary Outcome Measures :
  1. PC20 response of two dose levels of gefapixant compared with placebo in subjects with asthma after provocation with inhaled ATP. [ Time Frame: 3.5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Non-smokers or former smokers, who stopped smoking 6 months prior to screening. Former smokers should not have a smoking history of more than 5 pack years (1 pack of 20 cigarettes per day over 5 years).

Pre-bronchodilator (after abstaining from Short acting β2-agonist for ≥8 hrs) Forced Expiratory Volume (FEV1) ≥70% of the predicted normal value at the screening visit.

Pre-bronchodilator (after abstaining from Short acting β2-agonist for ≥8 hrs) Forced Expiratory Volume (FEV1) ≥70% of the predicted normal value OR if less than 70% must be within +/- 12 % of screening FEV1 prior to randomization.

History or diagnosis of asthma for at least 6 months prior to screening according to the Global Initiative in Asthma guidelines (GINA, 2012).

Use of Short acting β2-agonist therapy only (≤ 8 puffs per day) for at least 4 weeks prior to screening and prior to randomisation.

Positive response to methacholine challenge (PC20 ≤ 8 mg/mL) at screening.

Positive response to ATP challenge (PC20 ≤ 200 µmol/mL) at screening.

Exclusion Criteria:

Hospitalized or attended the emergency department for an asthma attack in the 12 months prior to screening.

Exacerbation of asthma or lower respiratory tract infection during the 4 weeks before screening.

Upper respiratory tract infection during the 4 weeks before screening or prior to randomization requiring treatment with antibiotics.

Inhaled or systemic corticosteroids (oral, intravenous, intramuscular) within 4 weeks prior to screening.

Short-acting or long-acting antihistamines within 48hrs or 7 days, respectively, prior to screening.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993329


Locations
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United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Afferent Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Dave Singh, MRCP, MD, CCST Medicines Evaluation Unit

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Responsible Party: Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01993329     History of Changes
Other Study ID Numbers: 7264-009
AF219-009 ( Other Identifier: Afferent Pharmaceuticals )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methacholine Chloride
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action