HealthyPhase 1NCT02790840
A Multiple-Dose Pharmacokinetics Study of Three Gefapixant (AF-219/MK-7264) Formulations
A Phase 1 study testing Omeprazole and Gefapixant in people with Healthy, run by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of three gefapixant (AF-219) formulations; to assess the effect of Omeprazole on the multiple dose PK of three gefapixant formulations; and, to 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
- 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2016to 21 Jun 2016
- 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
- Be informed of the nature of the study and have provided written informed voluntary consent
- Be able to speak, read, and understand English;
- Be healthy males or females, of any race, between 18 and 55 years of age, inclusive;
- Have a body mass index (BMI) >18.5 and <32.0 kg/m2 and weigh 50 - 100 kg;
- Be in good general health with no clinically relevant abnormalities based on the medical history, physical examination, clinical laboratory evaluations (hematology, clinical chemistry, and urinalysis), and 12-lead electrocardiogram;
- Be only non-smokers or intermittent (social) smokers for at least 5 years, and able to refrain from smoking (or using nicotine) while in confinement;
- If a female of child-bearing potential or not post-menopausal, agree to use 2 forms of acceptable birth control;
- Be able to communicate effectively with the Investigator and other study center personnel and agree to comply with the study procedures and restrictions
Who cannot join
- Have previously received gefapixant;
- 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;
- QTcB >450 msec in males or >470 msec in females;
Show all 15Show fewer
- 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 (other than allowable oral and implanted contraceptives and with the exception of vitamins taken at standard supplement doses); use of a drug therapy (including herbal preparations, e.g., St. John's wort) known to induce or inhibit hepatic drug metabolism within 30 days before the first dose of study medication; or use of any medications [prescription or over-the-counter (OTC)], including antacids, high-dose multivitamins, nutritional supplements, and herbal preparations, within 14 days before the first dose of study drug, unless deemed acceptable by the Investigator and Sponsor;
- Past or current history or evidence of drug or alcohol abuse, regular use of more than 2 units of alcohol per day (1 unit of alcohol = 150 mL of wine, 360 mL of beer, or 45 mL of alcohol 40%), 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 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study in Healthy Subjects to Assess the Multiple- Dose Pharmacokinetics of Three AF-219 Formulations
The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of three gefapixant (AF-219) formulations; to assess the effect of Omeprazole on the multiple dose PK of three gefapixant formulations; and, to assess the safety and tolerability of gefapixant.
- Conditions
- Healthy
- Being tested
- Omeprazole, Gefapixant
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Prilosec
20 mg oral capsules administered once daily for 10 days
OmeprazoleDrug
Also called Prilosec
40 mg oral capsules administered twice daily for 10 days
GefapixantDrug
Also called AF-219, MK-7264
Gefapixant oral tablets (15 mg administered as two 7.5 mg tablets) administered twice daily for 15 days
GefapixantDrug
Also called AF-219, MK-7264
Gefapixant oral tablets (30 mg administered as four 7.5 mg tablets) administered twice daily for 15 days
| Study group | Role | What they receive |
|---|---|---|
| Gefapixant + Omeprazole | Experimental | Gefapixant oral tablets (15mg and 30 mg) administered twice daily for 15 days + Omeprazole oral capsules (20 mg or 40 mg) administered once or twice daily for 10 days Receives: Drug: Omeprazole; Drug: Gefapixant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) profiles of three different oral formulations of gefapixant
Plasma gefapixant concentration versus time profiles will be plotted for each subject; similar summary plots will be constructed for each treatment period. Plasma gefapixant PK parameters will be calculated using noncompartmental methods and summarized using descriptive statistics by each treatment.
Measured: 12 hours
Maximum plasma concentration (Cmax) profile of gefapixant following administration of Omeprazole
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
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start16 May 2016
- Primary completion15 Jun 2016
- Study completion21 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- None (open label)
- Enrolment
- 32 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
- Danielle Armas, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790840
- Sponsor's protocol ID
- 7264-023
- Other IDs
- AF219-023
- Status last verified
- Apr 2017
- First submitted
- 27 May 2016
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Healthy Subjects to Assess the Multiple- Dose Pharmacokinetics of Three AF-219 Formulations
- ClinicalTrials.gov ID
- NCT02790840
- Acronym / sponsor ID
- 7264-023
- Conditions
- Healthy
- Keywords
- Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 16 May 2016 (actual)
- Primary completion
- 15 Jun 2016 (actual)
- Study completion
- 21 Jun 2016 (actual)
- First posted
- 6 Jun 2016 (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 compare the multiple dose pharmacokinetics (PK) of three gefapixant (AF-219) formulations; to assess the effect of Omeprazole on the multiple dose PK of three gefapixant formulations; and, to assess the safety and tolerability of gefapixant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gefapixant + Omeprazole | Experimental | Drug: Omeprazole, Drug: GefapixantGefapixant oral tablets (15mg and 30 mg) administered twice daily for 15 days + Omeprazole oral capsules (20 mg or 40 mg) administered once or twice daily for 10 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Be informed of the nature of the study and have provided written informed voluntary consent
- Be able to speak, read, and understand English;
- Be healthy males or females, of any race, between 18 and 55 years of age, inclusive;
- Have a body mass index (BMI) >18.5 and <32.0 kg/m2 and weigh 50 - 100 kg;
- Be in good general health with no clinically relevant abnormalities based on the medical history, physical examination, clinical laboratory evaluations (hematology, clinical chemistry, and urinalysis), and 12-lead electrocardiogram;
Key exclusion criteria (15 listed)
- Have previously received gefapixant;
- 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;
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: Prilosec20 mg oral capsules administered once daily for 10 days | Drug | Gefapixant + Omeprazole |
| OmeprazoleAlso: Prilosec40 mg oral capsules administered twice daily for 10 days | Drug | Gefapixant + Omeprazole |
| GefapixantAlso: AF-219, MK-7264Gefapixant oral tablets (15 mg administered as two 7.5 mg tablets) administered twice daily for 15 days | Drug | Gefapixant + Omeprazole |
| GefapixantAlso: AF-219, MK-7264Gefapixant oral tablets (30 mg administered as four 7.5 mg tablets) administered twice daily for 15 days | Drug | Gefapixant + Omeprazole |
Primary outcome
Maximum plasma concentration (Cmax) profiles of three different oral formulations of gefapixant
Time frame: 12 hours
Plasma gefapixant concentration versus time profiles will be plotted for each subject; similar summary plots will be constructed for each treatment period. Plasma gefapixant PK parameters will be calculated using noncompartmental methods and summarized using descriptive statistics by each treatment.
Maximum plasma concentration (Cmax) profile of gefapixant following administration of Omeprazole
Time frame: 12 hours
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
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 18 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Danielle Armas, MD principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omeprazole and Gefapixant in people with Healthy, 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 8 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 18 Apr 2017. 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 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?
Maximum plasma concentration (Cmax) profiles of three different oral formulations of gefapixant (time frame: 12 hours). The study lists 2 primary outcomes in all. 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 18 Apr 2017.