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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02477709
• Date of registration: 17/06/2015
• Prospective Registration: Yes
• Primary sponsor: Afferent Pharmaceuticals, Inc.
• Public title: A Study to Assess the Tolerability of a Single Dose of Gefapixant (AF-219/MK-7264) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
• Scientific 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)
• Date of first enrolment: July 20, 2015
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02477709
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Selwyn Spangenthal
• Affiliation: American Health Research

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Gefapixant

Primary Outcome(s)

Effect of Gefapixant on BP [Time Frame: 6 hours]

Secondary ID(s)

AF219-019

7264-019

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02477709