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A Study to Assess the Tolerability of a Single Dose of Gefapixant (AF-219/MK-7264) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

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ClinicalTrials.gov Identifier: NCT02477709
Recruitment Status : Completed
First Posted : June 23, 2015
Results First Posted : March 17, 2017
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.

Study Description
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Brief Summary:
This study assesses the tolerability of a single dose of gefapixant (AF-219) in participants with idiopathic pulmonary fibrosis (IPF). Six eligible participants will receive a single 150 mg dose of gefapixant and undergo tolerability and PK assessments.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Gefapixant Phase 2

Detailed Description:

This study assesses the tolerability of a single dose of gefapixant in participants with idiopathic pulmonary fibrosis (IPF).

This will be the first experience of administering gefapixant in patients with IPF. P2X3 receptors are found on the chemosensory afferents of the carotid body and can influence sympathetic autonomic discharge, especially in sensitized subjects; accordingly, by blocking these P2X3 receptors, gefapixant may have an effect of reducing sympathetic activity. Therefore in order to determine whether P2X3 antagonism would have an effect on the hemodynamic measures such as blood pressure in patients with IPF, study AF219-019 is being performed. These patients will be closely monitored in order to determine any such effect.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Assess the Tolerability of a Single Dose of AF-219, a P2X3 Receptor Antagonist, in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Actual Study Start Date : July 20, 2015
Actual Primary Completion Date : August 7, 2015
Actual Study Completion Date : August 21, 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Gefapixant
Gefapixant oral tablets (150 mg) administered as a single dose
 Drug: Gefapixant
Gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
Other Names:
  • AF-219
  • MK-7264


Outcome Measures
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Primary Outcome Measures :
  1. Effect of Gefapixant on BP [ Time Frame: 6 hours ]
    BP data will be summarized using descriptive statistics


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic pulmonary fibrosis diagnosis based upon the American Thoracic Society (ATS)/ European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/ Latin American Thoracic Society (ALAT) IPF 2011 guideline
  • Life expectancy of greater than 6 months
  • Stable medical condition (IPF) for at least 4 weeks
  • Women of child-bearing potential must use 2 forms of an acceptable birth control method from Screening through the Follow-Up Visit
  • Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control, 1 of which must be a barrier method, and make no donation of sperm from Screening until 3 months after the last dose of study drug
  • Written informed consent
  • Willing and able to comply with all aspects of the protocol

Exclusion Criteria:

  • Current smoker (i.e., within the last 30 days)
  • Initiation of treatment with an antihypertensive agent within 4 weeks prior to the day of dosing (Day 1) or during the study
  • History of upper respiratory tract infection within 4 weeks of the day of dosing (Day 1)
  • Requiring concomitant therapy with prohibited medications
  • Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2
  • History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including subjects with <3 excised basal cell carcinomas)
  • History of a diagnosis of drug or alcohol dependency or abuse within approximately the last 3 years
  • Any condition possibly affecting drug absorption (e.g., gastrectomy, gastroplasty, fundoplication, any type of bariatric surgery, vagotomy, or bowel resection)
  • Recent history of stroke or transient ischemic attack (within 6 months prior to Screening) not due to trauma, repaired vascular malformation, or aneurysm
  • Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
  • QTc interval >450 milliseconds in males, >470 milliseconds in females
  • Breastfeeding
  • Treatment with an investigational drug or biologic within 30 days preceding the first dose of study medication or plans to take another investigational drug or biologic within 30 days of study completion
  • Blood donation within 56 days or plasma donation within 7 days prior to dosing
  • Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the subject inappropriate for entry into this trial
Contacts and Locations
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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): NCT02477709


Locations
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United States, North Carolina
American Health Research
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Afferent Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Selwyn Spangenthal American Health Research
More Information
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Responsible Party: Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02477709    
Other Study ID Numbers: 7264-019
AF219-019 ( Other Identifier: Afferent Pharmaceuticals )
First Posted: June 23, 2015    Key Record Dates
Results First Posted: March 17, 2017
Last Update Posted: June 25, 2019
Last Verified: June 2019
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:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases