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NCT02477709

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

Completed Phase 2 Results posted Last updated 25 June 2019
What this trial tests

Phase 2 trial testing Gefapixant in Idiopathic Pulmonary Fibrosis in 6 participants. Completed in 21 August 2015.

Timeline
20 July 2015
Primary endpoint
7 August 2015
21 August 2015

Quick facts

Lead sponsorAfferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date20 July 2015
Primary completion7 August 2015
Estimated completion21 August 2015
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →

Who can join

40 and older, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Effect of Gefapixant on BP Primary · 6 hours

BP data will be summarized using descriptive statistics

Mean Systolic BP at 6 hrs
GroupValue95% CI
Gefapixant12290 – 142
Mean Diastolic BP at 6 hrs
GroupValue95% CI
Gefapixant7656 – 96

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gefapixant
Serious: 0/6 (0%)
Deaths:
Other adverse events (9 terms — click to expand)

ReactionSystemGefapixant
HypogeusiaNervous system disorders
DysgeusiaNervous system disorders
Decreased AppetiteMetabolism and nutrition disorders
PainGeneral disorders
Feeling HotGeneral disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Local SwellingGeneral disorders
AstheniaGeneral disorders
Vision BlurredEye disorders

Data from ClinicalTrials.gov NCT02477709 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Ion channels as therapeutic antibody targets.
    Hutchings CJ, Colussi P, Clark TG. · · 2019 · cited 89× · PMID 30526315 · DOI 10.1080/19420862.2018.1548232
  2. Purinergic Signaling in Endometriosis-Associated Pain.
    Trapero C, Martín-Satué M. · · 2020 · cited 18× · PMID 33198179 · DOI 10.3390/ijms21228512
  3. P2X Receptors: Potential Therapeutic Targets for Symptoms Associated With Lung Cancer - A Mini Review.
    Mai Y, Guo Z, Yin W, Zhong N, et al · · 2021 · cited 17× · PMID 34268121 · DOI 10.3389/fonc.2021.691956
  4. The developmental journey of therapies targeting purine receptors: from basic science to clinical trials.
    Han S, Suzuki-Kerr H, Vlajkovic SM, Thorne PR. · · 2022 · cited 9× · PMID 36173587 · DOI 10.1007/s11302-022-09896-w

Verify or expand the search:

Other trials of Gefapixant

Trials testing the same drug.

Other recruiting trials for Idiopathic Pulmonary Fibrosis

Currently open trials in the same condition.

Other Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02477709.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing