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Phase 2 N=6 Treatment

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

Idiopathic Pulmonary Fibrosis

Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Effect of Gefapixant on BP — 122; 76 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Gefapixant (Drug)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Primary completion
Aug 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Effect of Gefapixant on BP
122; 76

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.

Eligibility 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) 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02477709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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