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A study to find out if people get the same amount of medicine (alectinib) - when they take different forms of the medicine - with or without food.
A randomized, open-label, two-treatment, two-part, study to explore the performance of alectinib extemporaneous suspension on alectinib capsule bioavailability in healthy subjects in fed and fasted conditions.
- Healthy Volunteers
Trial Status:
Completed
This trial runs in
Cities
Trial Identifier:
GP42776
Trial Summary
Healthy volunteers for Group 1 (n=14) and Group 2 (n=7 high fat meals; n=7 low fat meals) were enrolled at one study site in the United Kingdom to explore the relative bioavailability of alectinib from oral suspension and hard capsule formulation in healthy subjects under fasted (Group 1) and fed (Group 2) conditions. All 28 participants completed the study. Results showed an increase in alectinib systemic exposure for oral suspension compared to capsule, that was higher in the fed state than in the fasted state. Adverse events (AEs) regardless of attribution occurred in 11 subjects. Three subjects experience related AEs. There were no deaths or serious AEs, and no discontinuations or modifications of the study treatment.
Genentech, Inc.
Sponsor
GP42776
Trial Identifier
All
Gender
18 to 60 Years
Age
Yes
Healthy Volunteers
This clinical trial was done to study a medicine called, “alectinib”, for the treatment of patients with cancer. This study investigated how much medicine was available in the body (relative bioavailability) in different formulations - when alectinib was taken as an oral suspension and as hard capsules - taken without food (Group 1) and with food (Group 2). Twenty-eight healthy people took part in this study in one country.
Trial Summary
Healthy volunteers for Group 1 (n=14) and Group 2 (n=7 high fat meals; n=7 low fat meals) were enrolled at one study site in the United Kingdom to explore the relative bioavailability of alectinib from oral suspension and hard capsule formulation in healthy subjects under fasted (Group 1) and fed (Group 2) conditions. All 28 participants completed the study. Results showed an increase in alectinib systemic exposure for oral suspension compared to capsule, that was higher in the fed state than in the fasted state. Adverse events (AEs) regardless of attribution occurred in 11 subjects. Three subjects experience related AEs. There were no deaths or serious AEs, and no discontinuations or modifications of the study treatment.
Genentech, Inc.
Sponsor
GP42776
Trial Identifier
Alectinib
Treatments
None for healthy volunteers
Condition
Official Title
A randomized, open-label, two-treatment, two-part, study to explore the performance of alectinib extemporaneous suspension on alectinib capsule bioavailability in healthy subjects in fed and fasted conditions.
Eligibility Criteria
All
Gender
18 to 60 Years
Age
Yes
Healthy Volunteers
For the latest version of this information please go to www.forpatients.roche.com