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

NCT ID: NCT02790840

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-16
• Study Completion Date: 2016-06-21

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gefapixant + Omeprazole

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

Group Type: EXPERIMENTAL

Omeprazole

Intervention Type: DRUG

20 mg oral capsules administered once daily for 10 days

Omeprazole

Intervention Type: DRUG

40 mg oral capsules administered twice daily for 10 days

Gefapixant

Intervention Type: DRUG

Gefapixant oral tablets (15 mg administered as two 7.5 mg tablets) administered twice daily for 15 days

Gefapixant

Intervention Type: DRUG

Gefapixant oral tablets (30 mg administered as four 7.5 mg tablets) administered twice daily for 15 days

Interventions

Omeprazole

20 mg oral capsules administered once daily for 10 days

Intervention Type: DRUG

Omeprazole

40 mg oral capsules administered twice daily for 10 days

Intervention Type: DRUG

Gefapixant

Gefapixant oral tablets (15 mg administered as two 7.5 mg tablets) administered twice daily for 15 days

Intervention Type: DRUG

Gefapixant

Gefapixant oral tablets (30 mg administered as four 7.5 mg tablets) administered twice daily for 15 days

Intervention Type: DRUG

Other Intervention Names

Prilosec; Prilosec; AF-219; MK-7264; AF-219; MK-7264

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Armas, MD

Role: PRINCIPAL_INVESTIGATOR

Celerion

Locations

Celerion

Tempe, Arizona, United States

Countries

United States

Other Identifiers

AF219-023

Identifier Type: OTHER

Identifier Source: secondary_id

7264-023

Identifier Type: -

Identifier Source: org_study_id