Idiopathic Pulmonary FibrosisPhase 2NCT02477709
A Study to Assess the Tolerability of a Single Dose of Gefapixant (AF-219/MK-7264) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing Gefapixant in people with Idiopathic Pulmonary Fibrosis, run by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Gefapixant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2015to 21 Aug 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
American Health Research
Charlotte, North Carolina, 28207
About this study
Official 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)
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.
Read the detailed description
This study assesses the tolerability of a single dose of gefapixant in participants with idiopathic pulmonary fibrosis (IPF).
This will be the first experience of administering gefapixant in patients with IPF. P2X3 receptors are found on the chemosensory afferents of the carotid body and can influence sympathetic autonomic discharge, especially in sensitized subjects; accordingly, by blocking these P2X3 receptors, gefapixant may have an effect of reducing sympathetic activity. Therefore in order to determine whether P2X3 antagonism would have an effect on the hemodynamic measures such as blood pressure in patients with IPF, study AF219-019 is being performed. These patients will be closely monitored in order to determine any such effect.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Gefapixant
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefapixantDrug
Also called AF-219, MK-7264
Gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
| Study group | Role | What they receive |
|---|---|---|
| Gefapixant | Experimental | Gefapixant oral tablets (150 mg) administered as a single dose Receives: Drug: Gefapixant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Gefapixant on BP
BP data will be summarized using descriptive statistics
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study start20 Jul 2015
- Primary completion7 Aug 2015
- Study completion21 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Selwyn Spangenthal, Principal investigator, American Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477709
- Sponsor's protocol ID
- 7264-019
- Other IDs
- AF219-019
- Status last verified
- Jun 2019
- First submitted
- 17 Jun 2015
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT02477709
- Acronym / sponsor ID
- 7264-019
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2015 (actual)
- Primary completion
- 7 Aug 2015 (actual)
- Study completion
- 21 Aug 2015 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Posted 17 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study assesses the tolerability of a single dose of gefapixant in participants with idiopathic pulmonary fibrosis (IPF).
This will be the first experience of administering gefapixant in patients with IPF. P2X3 receptors are found on the chemosensory afferents of the carotid body and can influence sympathetic autonomic discharge, especially in sensitized subjects; accordingly, by blocking these P2X3 receptors, gefapixant may have an effect of reducing sympathetic activity. Therefore in order to determine whether P2X3 antagonism would have an effect on the hemodynamic measures such as blood pressure in patients with IPF, study AF219-019 is being performed. These patients will be closely monitored in order to determine any such effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gefapixant | Experimental | Drug: GefapixantGefapixant oral tablets (150 mg) administered as a single dose |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GefapixantAlso: AF-219, MK-7264Gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only | Drug | Gefapixant |
Primary outcome
Effect of Gefapixant on BP
Time frame: 6 hours
BP data will be summarized using descriptive statistics
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selwyn Spangenthal principal investigator
American Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefapixant in people with Idiopathic Pulmonary Fibrosis, run by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Gefapixant on BP (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.