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

A Study to Assess the Tolerability of a Single Dose of AF-219, a P2X3 Receptor Antagonist, in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Gefapixant

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • American Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Gefapixant on BP	BP data will be summarized using descriptive statistics	6 hours

Collaborators and Investigators

• Sponsor: Afferent Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Selwyn Spangenthal, American Health Research

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2015
• Primary Completion (Actual): August 7, 2015
• Study Completion (Actual): August 21, 2015

Study Registration Dates

• First Submitted: June 17, 2015
• First Submitted That Met QC Criteria: June 18, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 7264-019; AF219-019 (Other Identifier: Afferent Pharmaceuticals)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf