A study to compare two different formulations of fenebrutinib and to assess the effect of food and rabeprazole on the processing of fenebrutinib by the body in healthy participants
- Conditions
- Healthy participantsNot Applicable
- Registration Number
- ISRCTN23183841
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 84
1. Males or females, between 18 and 60 years of age, inclusive.
2. Body weight =45 kilograms (kg) and within body mass index (BMI) range of 18 to 32 kilogram per meter square (kg/m²), inclusive.
3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), and vital signs.
4. Clinical laboratory evaluations (including chemistry panel [fasted at least 8 hours], complete blood count (CBC), and coagulation testing [prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (aPTT)]) and urinalysis (UA) with complete microscopic analysis are within the reference range for the test laboratory, or clinically acceptable to the investigator if outside the normal range.
5. Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (Day -1; does include alcohol).
6. Negative hepatitis panel (hepatitis B surface antigen [HBsAg], hepatitis B virus core antibody, hepatitis B surface antibody [unless consistent with vaccination or immunity due to natural infection], and hepatitis C virus antibody) and negative HIV antibody screens.
7. For females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraception, and agreement to refrain from donating eggs, as defined in the protocol.
8. For males: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom with spermicide, and agreement to refrain from donating sperm, as defined in the protocol.
9. Any participant (male or female) who is abstinent or in a homosexual relationship at the time of signing ICF and becomes sexually active or in a heterosexual relationship during the above-defined period must agree to use a highly effective contraception as listed above.
10. For Part 2: able to complete a standard high-fat meal within 30 minutes.
11. Able to comprehend and willing to sign an informed consent form (ICF).
1. Participants who are pregnant or breastfeeding or intending to become pregnant during the study or within 28 days after the final dose of the study drug. Females must have a negative serum pregnancy test result at Screening and Check-in (Day -1)
2. Evidence of any infectious, metabolic, allergic, dermatological, hepatic (including Gilbert’s syndrome), renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder that, in the investigator’s opinion, would preclude subject participation
3. Known or suspected active infection at Screening or baseline (excluding onychomycosis), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks prior to or during Screening or treatment with oral antimicrobials within 2 weeks prior to or during Screening
4. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
5. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except for appendectomy or hernia repair which will be allowed.
6. Participation in any other trial in which receipt of an investigational study drug occurred within 3 months or 5 half-lives, whichever is longer, prior to Check-in (Day -1)
7. History of any drug or alcohol abuse within 12 months prior to Screening and/or alcohol consumption of >2 units per day for males and >1 unit per day for females. One unit of alcohol equals 285 mL of beer or lager, 25 mL liquor, or 84 mL wine
8. Use of any moderate or strong CYP3A inhibitor or inducer within 30 days or 5 half-lives, whichever is longer, prior to Check-in (Day -1)
9. Dyspepsia, gastroesophageal reflux disease (GERD), ulcer, or GI symptoms for which the subject has recently taken (within 14 days prior to Check-in [Day -1]) prescription or over-the-counter proton pump inhibitors (PPIs), H2 blockers, or antacids for the control of gastric acidity
10. Use of any prescription medications/products within 14 days or 5 half-lives, whichever is longer, prior to Check-in (Day -1), unless deemed acceptable by the investigator
11. Use of any over-the-counter, non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 14 days or 5 half-lives, whichever is longer, prior to Check-in (Day -1), unless deemed acceptable by the investigator
12. Participants vaccinated with live, attenuated vaccines (e.g., the intranasal live attenuated influenza vaccines, Bacillus Calmette- Guérin virus, varicella) within 6 weeks prior to first dosing (Day 1 of Period 1)
13. History of pancreatitis, cholecystectomy or gallstones, or clinically significant GI ulcer or bleeding
14. Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Check-in (Day -1) and during the entire study
15. Use of furanocoumarin derivatives (e.g., grapefruit, Seville oranges, pomegranates, or star fruit) or poppy seed-containing foods or beverages within 7 days prior to Check-in (Day -1), unless deemed acceptable by the investigator
16. Use of alcohol- or caffeine-containing foods or beverages within 48 hours prior to Check-in (Day -1), unless deemed acceptable by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method