Cancer Cancer
Conditions
Interventions
Participants will receive a single oral 600 mg dose of one of the following across six study periods:
1. Reference alectinib capsule in the fasted state
2. Alectinib powder for oral suspension in the
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males or non-pregnant, non-lactating healthy females of non-childbearing potential 2. Aged 18 to 55 years inclusive at the time of signing informed consent 3. Body mass index (BMI) of 18.0 to 32.0 kg/m² as measured at screening 4. Must be willing and able to communicate and participate in the whole study 5. Must provide written informed consent 6. Must agree to adhere to the contraception requirements defined in the protocol
Exclusion criteria
Exclusion criteria: 1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1 2. Subjects who are, or are immediate family members of, a study site or sponsor employee 3. Evidence of current SARS-CoV-2 infection. Subjects who have previously had evidence of COVID-19 infection may be permitted to continue in future treatment periods, on a case by case basis, as per the judgement of the investigator and sponsors’ medical monitor, provided the subject is asymptomatic, has recovered, a minimum of 14 days have passed since the initial diagnosis, and the subject has a negative PCR or antigen test before admission to the clinical unit. 4. History of any drug or alcohol abuse in the past 2 years 5. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type) 6. A confirmed positive alcohol breath test at screening or admission 7. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission. 8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months 9. Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative highly sensitive serum pregnancy test at screening and urine at all other time points). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone [FSH] concentration =40 IU/L). 10. Male subjects with pregnant or lactating partners 11. Clinically significant abnormal clinical chemistry, haematology or urinalysis at screening as judged by the investigator. Subjects will be excluded if they have ALT, aspartate aminotransferase or total bilirubin above the upper limit of the reference range or haemoglobin less than the lower limit of the reference range, neutrophil or lymphocyte count below the lower limit of normal or creatinine kinase 1.25 × the upper limit of the reference range without an alternative explanation (e.g. physical activity). 12. Confirmed positive drugs of abuse test result at screening or admission 13 Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results 14. Evidence of renal impairment at screening, as indicated by an eGFR of <80 ml/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula or any other evidence of renal impairment 15. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator or history of visual disturbances (e.g. blurred vision, vitreous floaters, visual impairment, reduced visual acuity, asthenopia, and diplopia) unless determined to be clinically not significant by agreement between the investigator and the sponsor’s medical monitor 16. Subjects with a history of cholecystectomy or gall stones 17. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients 18. Presence or history of clinically significant alle
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative bioavailability (Frel) for Cmax, AUC(0-last) and AUC(0-inf) of alectinib and its M4 metabolite for alectinib powder for oral suspension, alectinib oral powder and alectinib minitablet formulations compared to a reference alectinib capsule formulation in plasma, measured using blood samples at pre-dose and multiple timepoints up to 72 h post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic (PK) parameters, including but not limited to: Tlag, Tmax, Cmax, C24, AUC(0-last), AUC(0-inf), Lambda-z, T1/2, CL/F, Vz/F and metabolite parent ratios for alectinib and its M4 metabolite in plasma, measured using blood samples at pre-dose and multiple timepoints up to 72 h post-dose 2. Additional safety and tolerability information for alectinib collected by assessing adverse events (AEs), vital signs, electrocardiograms (ECGs), physical examinations and laboratory safety tests, from the time of signing the informed consent form up until the follow-up visit (up to 41 weeks) 3. Palatability, assessed using a 9-point rating scale immediately after dosing | — |
Countries
England, United Kingdom
Contacts
Public ContactWilliam Davidson
Outcome results
None listed