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

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ClinicalTrials.gov Identifier: NCT02477709
Recruitment Status : Completed
First Posted : June 23, 2015
Results First Posted : March 17, 2017
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Intervention Drug: Gefapixant
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gefapixant
Hide Arm/Group Description Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Gefapixant
Hide Arm/Group Description Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  33.3%
>=65 years
4
  66.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
1
  16.7%
Not Hispanic or Latino
5
  83.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  33.3%
White
4
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
BP   [1] 
Mean (Full Range)
Unit of measure:  mmHg
Number Analyzed 6 participants
Mean Baseline Systolic BP
122
(100 to 132)
Mean Baseline Diastolic BP
77
(60 to 92)
[1]
Measure Description: Blood Pressure
1.Primary Outcome
Title Effect of Gefapixant on BP
Hide Description BP data will be summarized using descriptive statistics
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gefapixant
Hide Arm/Group Description:
Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
Overall Number of Participants Analyzed 6
Mean (Full Range)
Unit of Measure: units on a scale
Mean Systolic BP at 6 hrs
122
(90 to 142)
Mean Diastolic BP at 6 hrs
76
(56 to 96)
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gefapixant
Hide Arm/Group Description Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
All-Cause Mortality
Gefapixant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gefapixant
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gefapixant
Affected / at Risk (%) # Events
Total   5/6 (83.33%)    
Eye disorders   
Vision Blurred  1  1/6 (16.67%)  1
General disorders   
Pain  1  1/6 (16.67%)  1
Feeling Hot  1  1/6 (16.67%)  1
Local Swelling  1  1/6 (16.67%)  2
Asthenia  1  1/6 (16.67%)  1
Metabolism and nutrition disorders   
Decreased Appetite  1  1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/6 (16.67%)  1
Nervous system disorders   
Hypogeusia  1  3/6 (50.00%)  4
Dysgeusia  1  2/6 (33.33%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
60 days prior to the submission of any results, the PI shall submit to SPONSOR any proposed PUBLICATION, which period may be extended for an additional 30 days if requested by SPONSOR. If any Confidential Information should be redacted or patent applications relating to an Invention should be filed prior to PUBLICATION, then PUBLICATION will be delayed until patent application has been filed. Delay of a PUBLICATION shall not exceed 24 months from the date of such notice to the PI.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Afferent Pharmaceuticals, Inc.
Phone: 650-286-1276
EMail: info@afferentpharma.com
Layout table for additonal information
Responsible Party: Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02477709     History of Changes
Other Study ID Numbers: 7264-019
AF219-019 ( Other Identifier: Afferent Pharmaceuticals )
First Submitted: June 17, 2015
First Posted: June 23, 2015
Results First Submitted: December 7, 2016
Results First Posted: March 17, 2017
Last Update Posted: June 25, 2019