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

NCT02477709 | Completed Phase 2 Results

• 2 other identifiers: 7264-019AF219-019
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Effect of Gefapixant on BP

  BP data will be summarized using descriptive statistics

  6 hours

Study Arms (1)

Gefapixant

EXPERIMENTAL

Gefapixant oral tablets (150 mg) administered as a single dose

Drug: Gefapixant

Interventions

Gefapixant DRUG

Gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only

Also known as: AF-219, MK-7264

Gefapixant

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Study Sites (1)

American Health Research

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Gefapixant

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Afferent Pharmaceuticals, Inc.

info@afferentpharma.com

650-286-1276

Study Officials

• Selwyn Spangenthal

  American Health Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 23, 2015
• Study Start: July 20, 2015
• Primary Completion: August 7, 2015
• Study Completion: August 21, 2015
• Last Updated: June 25, 2019
• Results First Posted: March 17, 2017

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)