Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Effect of Gefapixant (AF-219/MK-7264) on Methacholine Hyper-reactivity in Participants With Asthma (MK-7264-009)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993329
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.

Brief Summary:
This is a randomised, double blind, double-dummy, placebo-controlled, three-way cross-over, single centre study in participants with asthma undergoing inhalation of methacholine and adenosine triphosphate (ATP) to assess the provocative concentration (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 Phase 2

Layout table for study information
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 16, 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 50/ Gefapixant 300/ Placebo
Gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 1, gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 2, placebo to match gefapixant 50 mg and 300 mg twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period.
Drug: Gefapixant 50 mg
Gefapixant 50 mg tablet administered orally
Other Names:
  • AF-219
  • MK-7264

Drug: Gefapixant 300 mg
Gefapixant 300 mg tablet administered orally
Other Names:
  • AF-219
  • MK-7264

Drug: Placebo
Sugar pill manufactured to mimic gefapixant 50 mg and 300 mg tablets

Experimental: Gefapixant 50/ Placebo/ Gefapixant 300
Gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 1, placebo to match gefapixant 50 mg and 300 mg twice daily for 3.5 days during Period 2, gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period.
Drug: Gefapixant 50 mg
Gefapixant 50 mg tablet administered orally
Other Names:
  • AF-219
  • MK-7264

Drug: Gefapixant 300 mg
Gefapixant 300 mg tablet administered orally
Other Names:
  • AF-219
  • MK-7264

Drug: Placebo
Sugar pill manufactured to mimic gefapixant 50 mg and 300 mg tablets

Experimental: Gefapixant 300/ Gefapixant 50/ Placebo
Gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 1, gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 2, placebo to match gefapixant 50 mg and 300 mg twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period.
Drug: Gefapixant 50 mg
Gefapixant 50 mg tablet administered orally
Other Names:
  • AF-219
  • MK-7264

Drug: Gefapixant 300 mg
Gefapixant 300 mg tablet administered orally
Other Names:
  • AF-219
  • MK-7264

Drug: Placebo
Sugar pill manufactured to mimic gefapixant 50 mg and 300 mg tablets

Experimental: Gefapixant 300/ Placebo/ Gefapixant 50
Gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 1, placebo to match gefapixant 50 mg and 300 mg twice daily for 3.5 days during Period 2, gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period.
Drug: Gefapixant 50 mg
Gefapixant 50 mg tablet administered orally
Other Names:
  • AF-219
  • MK-7264

Drug: Gefapixant 300 mg
Gefapixant 300 mg tablet administered orally
Other Names:
  • AF-219
  • MK-7264

Drug: Placebo
Sugar pill manufactured to mimic gefapixant 50 mg and 300 mg tablets

Experimental: Placebo/ Gefapixant 50/ Gefapixant 300
Placebo to match gefapixant 50 mg and 300 mg twice daily for 3.5 days during Period 1, gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 2, gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period.
Drug: Gefapixant 50 mg
Gefapixant 50 mg tablet administered orally
Other Names:
  • AF-219
  • MK-7264

Drug: Gefapixant 300 mg
Gefapixant 300 mg tablet administered orally
Other Names:
  • AF-219
  • MK-7264

Drug: Placebo
Sugar pill manufactured to mimic gefapixant 50 mg and 300 mg tablets

Experimental: Placebo/ Gefapixant 300/ Gefapixant 50
Placebo to match gefapixant 50 mg and 300 mg twice daily for 3.5 days during Period 1, gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 2, gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period.
Drug: Gefapixant 50 mg
Gefapixant 50 mg tablet administered orally
Other Names:
  • AF-219
  • MK-7264

Drug: Gefapixant 300 mg
Gefapixant 300 mg tablet administered orally
Other Names:
  • AF-219
  • MK-7264

Drug: Placebo
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. Change from baseline in Forced Expiratory Volume in 1 Second (FEV1) after methacholine challenge [ Time Frame: 3.5 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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) FEV1 ≥70% of the predicted normal value at the screening visit.

Pre-bronchodilator (after abstaining from Short acting β2-agonist for ≥8 hrs) 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


Sponsors and Collaborators
Afferent Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Dave Singh, MRCP, MD, CCST Medicines Evaluation Unit
Layout table for additonal information
Responsible Party: Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01993329    
Other Study ID Numbers: 7264-009
AF219-009 ( Other Identifier: Afferent Pharmaceuticals )
2013-003566-13 ( EudraCT Number )
MK-7264-009 ( Other Identifier: Merck )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases