A study to assess the distribution and effect of food and pH on belvarafenib in the blood of healthy adults
- Conditions
- Healthy participantsNot Applicable
- Registration Number
- ISRCTN47564876
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 66
1. Males or females of non-childbearing potential, between 18 and 65 years of age, inclusive
2. Within body mass index (BMI) range 18 to 32 kilograms per square meter (kg/m^2), inclusive, at Screening
3. Females will not be pregnant or breastfeeding and must be either postmenopausal or surgically sterile. For all females, the pregnancy test result must be negative at Screening and Period 1 Check-in (Day -1)
4. Negative screening test for latent Mycobacterium tuberculosis (TB) infection by QuantiFERON® TB Gold. Indeterminate results may be confirmed by repeat or by a purified protein derivative (PPD) skin test
1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
2. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that uncomplicated appendectomy and hernia repair will be allowed
3. History of acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) as determined by the investigator (or designee) at Screening or Period 1 Check-in (Day -1)
4. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 90 days, whichever is longer, prior to study entry
5. Treatment with intravenous antibiotics within 8 weeks or oral antibiotics within 4 weeks prior to Screening or during the entire study duration
6. Use of any drugs known to be moderate or strong inhibitors or inducers of CYP3A, and for Cohort 2b CYP2C19, within 30 days prior to Period 1 Check-in (Day -1) and during the entire study duration
7. Poor peripheral venous access
8. History of malignancy within 5 years prior to enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Cohort 1a: The geometric mean ratio (GMR) and associated 90% confidence intervals (CIs) of maximum observed plasma concentration (Cmax), concentration versus time curve from time zero extrapolated to infinity (AUC0-8), and AUC from hour 0 to the last measurable concentration (AUC0-t) following administration of belvarafenib HCl and belvarafenib MSA formulation after low-fat meal<br>2. Cohort 1b: Dose-normalized Cmax, AUC0-8, and AUC0-t following administration of different dose levels of belvarafenib MSA formulation after low-fat meal<br>3. Cohort 2a: The GMR and associated 90% CIs of Cmax, AUC0-8, and AUC0-t following administration of belvarafenib MSA formulation after high-fat meal and in the fasted state<br>4. Cohort 2b: The GMR and associated 90% CIs of Cmax, AUC0-8, and AUC0-t following administration of belvarafenib MSA formulation alone and co-administered with rabeprazole after low-fat meal<br><br>Timeframe: PK outcomes measured using blood samples collected from Day 1 up to Day 14
- Secondary Outcome Measures
Name Time Method