Trial Outcomes & Findings for A Study to Assess the Tolerability of a Single Dose of Gefapixant (AF-219/MK-7264) in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT02477709)
NCT ID: NCT02477709
Last Updated: 2019-06-25
Results Overview
BP data will be summarized using descriptive statistics
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
6 hours
Results posted on
2019-06-25
Participant Flow
Participant milestones
| Measure |
Gefapixant
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 Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Tolerability of a Single Dose of Gefapixant (AF-219/MK-7264) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Baseline characteristics by cohort
| Measure |
Gefapixant
n=6 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
|
BP
Mean Baseline Systolic BP
|
122 mmHg
n=5 Participants
|
|
BP
Mean Baseline Diastolic BP
|
77 mmHg
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 hoursBP data will be summarized using descriptive statistics
Outcome measures
| Measure |
Gefapixant
n=6 Participants
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
|
|---|---|
|
Effect of Gefapixant on BP
Mean Systolic BP at 6 hrs
|
122 units on a scale
Interval 90.0 to 142.0
|
|
Effect of Gefapixant on BP
Mean Diastolic BP at 6 hrs
|
76 units on a scale
Interval 56.0 to 96.0
|
Adverse Events
Gefapixant
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gefapixant
n=6 participants at risk
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
|
|---|---|
|
Metabolism and nutrition disorders
Decreased Appetite
|
16.7%
1/6 • Number of events 1 • 2 weeks
|
|
Nervous system disorders
Hypogeusia
|
50.0%
3/6 • Number of events 4 • 2 weeks
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • 2 weeks
|
|
General disorders
Feeling Hot
|
16.7%
1/6 • Number of events 1 • 2 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • 2 weeks
|
|
General disorders
Local Swelling
|
16.7%
1/6 • Number of events 2 • 2 weeks
|
|
General disorders
Asthenia
|
16.7%
1/6 • Number of events 1 • 2 weeks
|
|
Eye disorders
Vision Blurred
|
16.7%
1/6 • Number of events 1 • 2 weeks
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • Number of events 2 • 2 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER