Clareo Health | A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy male and surgically sterile or post-menopausal female participants 18-55 years of age
Body mass index (BMI) between 18 to 32 kilograms per meter-squared (kg/m\^2)
Non-smoking participants and former smoking participants (who have not smoked for the past six months before first dosing)
Male participants and their partners of child-bearing potential must be willing to use two effective contraceptive methods as defined by protocol
Willing to abstain from xanthine-containing beverages and food (coffee, tea, cola, chocolate, and "energy drinks") from 72 hours prior to Day -1 through the study
Willing to abstain from grapefruit, pomelo, star fruit or Seville orange containing products from day 7 prior study start until study end
Willing to avoid prolonged sun exposure while taking RO5424802 and through follow-up
You may not be if
Pregnant or lactating women, men with female partners who are pregnant or lactating, or women of child bearing potential
Clinically significant abnormalities on physical examination, vital signs, or laboratory test results during screening or prior to admission to the study unit
Positive test for drugs of abuse, alcohol or cotinine test at screening or prior to admission to the study unit or suspicion of regular consumption of drug(s) of abuse
History of recent alcohol consumption exceeding 2 standard drinks per day on average. Alcohol consuming is prohibited from 72 hours prior to study start until the end of the study
Participants with any risk factors or family history for QT/QTcF and electrocardiogram (ECG) abnormalities
A history of any concurrent clinically significant hematologic, renal, hepatic, pulmonary, neurological, psychiatric, allergies, gastrointestinal, metabolic or endocrine disorder, or cardiovascular disease or infections
Positive screening test for hepatitis B, C, or human immunodeficiency virus (HIV)
Use of any medications (prescriptions or over-the-counter), within 2 weeks or 5 half-lives (whichever is longer) before the first dose of study medication with exception of acetaminophen up to 2 grams (g) per day up to 48 hours prior to dosing, not to exceed 4 g total during the week prior to dosing
Routine or chronic use of more than 2 g of acetaminophen daily
Use of any herbal supplements (for example, St. John's Wort) or any metabolic inducers within 4 weeks or 5 half-lives (whichever is longer) before the first dose of study medication, including but not limited to the following drugs: rifampin, rifabutin, glucocorticoids, carbamazepine, phenytoin, and phenobarbital
Strenuous activity, sunbathing or contact sports are not allowed from 4 days prior to study start until the end of the study
Participation in an investigational drug or device study within 45 days or 5 half-lives (whichever time period is longer), or 6 months for biologic therapies, prior to first dosing
Donation of blood over 450 milliliters (mL) within 45 days prior to screening
