Expired Study
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Tempe, Arizona 85283


Purpose:

The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of two gefapixant (AF-219) formulations; to assess the effect of omeprazole on the multiple dose PK of two gefapixant formulations; and, to assess the safety and tolerability of gefapixant.


Criteria:

Inclusion Criteria: - 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 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 (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; when in line with the preferred life style of the subject, true and complete abstinence (not periodic abstinence) is acceptable; Exclusion Criteria: - 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 >470 msec in females; - 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; - 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.


Study is Available At:


Original ID:

7264-020


NCT ID:

NCT02492776


Secondary ID:

AF219-020


Study Acronym:


Brief Title:

A Multiple-Dose Pharmacokinetics Study of Two Gefapixant (AF-219/MK-7264) Formulations


Official Title:

A Study in Healthy Subjects to Assess the Multiple-Dose Pharmacokinetics of Two AF-219 Formulations


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Afferent Pharmaceuticals, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

14


Enrollment Type:

Actual


Overall Contact Information

Official Name:Dennis Swearingen, MD
Principal Investigator
Celerion

Study Dates

Start Date:July 7, 2015
Completion Date:August 11, 2015
Completion Type:Actual
Primary Completion Date:August 4, 2015
Primary Completion Type:Actual
Verification Date:April 2017
Last Changed Date:April 17, 2017
First Received Date:June 15, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Plasma concentration profile of gefapixant following administration of omeprazole
Time Frame:5.5 hours
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Plasma concentration profiles of two different oral formulations of gefapixant
Time Frame:12 hours
Safety Issues:False
Description: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 us

Study Interventions

Intervention Type:Drug
Name:Omeprazole
Description:20 mg oral capsules administered once daily for 8 days
Arm Name:Gefapixant + Omeprazole
Other Name:Prilosec
Intervention Type:Drug
Name:Gefapixant
Description:Gefapixant oral tablet (25 mg administered as a divided 50 mg tablet) administered twice daily for 5 days
Arm Name:Gefapixant + Omeprazole
Other Name:AF-219
Intervention Type:Drug
Name:Gefapixant
Description:Gefapixant oral tablet (50 mg tablet) administered twice daily for 8 days
Arm Name:Gefapixant + Omeprazole
Other Name:AF-219

Study Arms

Study Arm Type:Experimental
Arm Name:Gefapixant + Omeprazole
Description:Gefapixant oral tablets (25mg, 50 mg) administered twice daily for 13 days + Omeprazole oral capsules (20 mg) administered once daily for 8 days

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Afferent Pharmaceuticals, Inc.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Celerion

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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