Healthy VolunteersPhase 1NCT02229877
A Study to Assess the Effect of Intragastric pH and Fasting on the Pharmacokinetics of Gefapixant (AF-219/MK-7264)
A Phase 1 study testing Omeprazole and Gefapixant in people with Healthy Volunteers, run by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
Trial summary
The purpose of this study is to: determine the effect of stomach pH on the multiple dose pharmacokinetics (PK) of gefapixant (AF-219); assess the effect of multiple doses of gefapixant on various sensory assessments; and, assess the safety and tolerability of gefapixant. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Omeprazole and Gefapixant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2014to 22 May 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be informed of the nature of the study and have provided written informed voluntary consent;
- Able to speak, read, and understand English;
- Healthy males or females, of any race, between 18 and 55 years of age, inclusive;
- Body mass index (BMI) >18.5 and <32.0 kg/m2 and weigh 50 - 100 kg;
- In good general health ;
- Non-smokers for at least 5 years;
- If a female of child-bearing potential (i.e., have not undergone a hysterectomy or bilateral oophorectomy) or not post-menopausal (defined as no menses for at least 12 months), agree to use 2 forms of acceptable birth control; or if a male, they and/or their partner of child-bearing potential agree to use 2 forms of acceptable birth control;
Who cannot join
- Any disease or condition that might affect drug absorption, metabolism, or excretion or clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease;
- Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication;
- Any past sinus surgery, upper respiratory tract infection within 2 weeks before dosing, or history of hay fever during the time of the year that dosing will be taking place;
- History of GERD, heartburn, or nausea more than once a month, or any similar symptoms requiring the regular use of antacids, or any use of H2 histamine blockers or proton pump inhibitors within 12 months of Screening;
- Have a positive screening test for Helicobacter pylori;
- QTcB >450 msec in males or >460 msec in females;
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- Known or suspected hypersensitivity or allergic reaction to any of the components of gefapixant or omeprazole capsules;
- If female, is pregnant or breast feeding, or has a positive pregnancy test pre dose;
- Blood loss or blood donation of >550 mL within 90 days or plasma donation >500 mL within 14 days before administration of the first dose of study drug;
- Chronic use of any systemic medications; use of a drug therapy known to induce or inhibit hepatic drug metabolism within 30 days before the first dose of study medication; or use of any medications including antacids, high dose multivitamins, nutritional supplements, and herbal preparations, within 14 days before the first dose of study drug;
- Past or current history or evidence of drug or alcohol abuse, use of any recreational soft drugs (e.g., marijuana) within 3 months of screening, use of any hard drugs (such as cocaine, phencyclidine (PCP), and crack) within 1 year of screening, and/or a positive screen for substances of abuse or alcohol at screening or pre dose;
- Ingestion of grapefruit or grapefruit juice within 48 hours before dose administration;
- Positive urine cotinine test at Screening or Day 1 pre dose;
- Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV) antibody;
- Receipt of an investigational product or device, or participation in a drug research study within a period of 30 days (or 5 half lives of the drug, whichever is longer) before the first dose of study medication;
- Receipt of an investigational immunomodulator or monoclonal antibody within 180 days (or 5 half lives, whichever is longer) before the first dose of study medication
About this study
Official title: A Study in Healthy Subjects to Assess the Effect of Intragastric pH and Fasting on the Multiple-Dose Pharmacokinetics of AF-219
The purpose of this study is to: determine the effect of stomach pH on the multiple dose pharmacokinetics (PK) of gefapixant (AF-219); assess the effect of multiple doses of gefapixant on various sensory assessments; and, assess the safety and tolerability of gefapixant.
- Conditions
- Healthy Volunteers
- Being tested
- Omeprazole, Gefapixant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Prilosec
40 mg oral capsules administered twice daily for 8.5 days
GefapixantDrug
Also called AF-219, MK-7264
Gefapixant oral tablet (25 mg administered as a divided 50 mg tablet) administered twice daily for 2 days
GefapixantDrug
Also called AF-219, MK-7264
Gefapixant oral tablet (50 mg tablet) administered twice daily for 8 days
GefapixantDrug
Also called AF-219, MK-7264
Gefapixant oral tablet (150 mg administered as three 50 mg tablets) administered twice daily for 8 days
| Study group | Role | What they receive |
|---|---|---|
| Gefapixant + Omeprazole | Experimental | Gefapixant oral tablets (25mg, 50 mg, 150 mg) administered twice daily for 18 days
+ Omeprazole oral capsules (40 mg) administered twice daily for 8.5 days Receives: Drug: Omeprazole; Drug: Gefapixant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Intragastric pH on gefapixant PK
Analysis of variance (ANOVA) will be performed on log normal-transformed Cmax and AUC0-t values to determine the extent of a drug interaction, if any, of omeprazole on the plasma gefapixant PK parameters. These analyses will be conducted for both fed and fasted conditions and the 50 mg and 150 mg treatments.
Measured: At pre-dose (time 0) and at 1, 2, 3, 5, 8, and 12 hours post dose
Secondary outcomes (1)
Effect of Fasting on gefapixant PK
ANOVA will be performed on log normal-transformed Cmax and AUC0-t values to determine if fasting affects plasma gefapixant PK parameters.
Measured: At pre-dose (time 0) and at 1, 2, 3, 5, 8, and 12 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study start6 Oct 2014
- Primary completion14 May 2015
- Study completion22 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 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)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Terry O'Reilly, M.D., Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229877
- Sponsor's protocol ID
- 7264-011
- Other IDs
- AF219-011
- Status last verified
- Jul 2022
- First submitted
- 27 Aug 2014
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Gupta P, Hussain A, Ford AP, Smith S, Nussbaum JC, Stoch A, Iwamoto M. Clinical Formulation Bridging of Gefapixant, a P2X3-Receptor Antagonist, for the Treatment of Chronic Cough. Clin Pharmacol Drug Dev. 2022 Sep;11(9):1054-1067. doi: 10.1002/cpdd.1105. Epub 2022 May 5.
PubMed 35510785
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Healthy Subjects to Assess the Effect of Intragastric pH and Fasting on the Multiple-Dose Pharmacokinetics of AF-219
- ClinicalTrials.gov ID
- NCT02229877
- Acronym / sponsor ID
- 7264-011
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 6 Oct 2014 (actual)
- Primary completion
- 14 May 2015 (actual)
- Study completion
- 22 May 2015 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to: determine the effect of stomach pH on the multiple dose pharmacokinetics (PK) of gefapixant (AF-219); assess the effect of multiple doses of gefapixant on various sensory assessments; and, assess the safety and tolerability of gefapixant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gefapixant + Omeprazole | Experimental | Drug: Omeprazole, Drug: GefapixantGefapixant oral tablets (25mg, 50 mg, 150 mg) administered twice daily for 18 days + Omeprazole oral capsules (40 mg) administered twice daily for 8.5 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Must be informed of the nature of the study and have provided written informed voluntary consent;
- Able to speak, read, and understand English;
- Healthy males or females, of any race, between 18 and 55 years of age, inclusive;
- Body mass index (BMI) >18.5 and <32.0 kg/m2 and weigh 50 - 100 kg;
- In good general health ;
Key exclusion criteria (16 listed)
- Any disease or condition that might affect drug absorption, metabolism, or excretion or clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease;
- Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication;
- Any past sinus surgery, upper respiratory tract infection within 2 weeks before dosing, or history of hay fever during the time of the year that dosing will be taking place;
- History of GERD, heartburn, or nausea more than once a month, or any similar symptoms requiring the regular use of antacids, or any use of H2 histamine blockers or proton pump inhibitors within 12 months of Screening;
- Have a positive screening test for Helicobacter pylori;
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 |
|---|---|---|
| OmeprazoleAlso: Prilosec40 mg oral capsules administered twice daily for 8.5 days | Drug | Gefapixant + Omeprazole |
| GefapixantAlso: AF-219, MK-7264Gefapixant oral tablet (25 mg administered as a divided 50 mg tablet) administered twice daily for 2 days | Drug | Gefapixant + Omeprazole |
| GefapixantAlso: AF-219, MK-7264Gefapixant oral tablet (50 mg tablet) administered twice daily for 8 days | Drug | Gefapixant + Omeprazole |
| GefapixantAlso: AF-219, MK-7264Gefapixant oral tablet (150 mg administered as three 50 mg tablets) administered twice daily for 8 days | Drug | Gefapixant + Omeprazole |
Primary outcome
Effect of Intragastric pH on gefapixant PK
Time frame: At pre-dose (time 0) and at 1, 2, 3, 5, 8, and 12 hours post dose
Analysis of variance (ANOVA) will be performed on log normal-transformed Cmax and AUC0-t values to determine the extent of a drug interaction, if any, of omeprazole on the plasma gefapixant PK parameters. These analyses will be conducted for both fed and fasted conditions and the 50 mg and 150 mg treatments.
1 secondary outcome
Effect of Fasting on gefapixant PK
Time frame: At pre-dose (time 0) and at 1, 2, 3, 5, 8, and 12 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Results publication: PubMed 35510785Gupta P, Hussain A, Ford AP, Smith S, Nussbaum JC, Stoch A, Iwamoto M. Clinical Formulation Bridging of Gefapixant, a P2X3-Receptor Antagonist, for the Treatment of Chronic Cough. Clin Pharmacol Drug Dev. 2022 Sep;11(9):1054-1067. doi: 10.1002/cpdd.1105. Epub 2022 May 5.
- 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.
Terry O'Reilly, M.D. principal investigator
Celerion
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omeprazole and Gefapixant in people with Healthy Volunteers, run by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
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 16 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 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Intragastric pH on gefapixant PK (time frame: At pre-dose (time 0) and at 1, 2, 3, 5, 8, and 12 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02229877, which also lists 1 linked publication.
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 22 Jul 2022.