A Study to Evaluate the Effect of High Fat Meal on Cabotegravir
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
Cabotegravir is being developed for the treatment of human immunodeficiency virus (HIV) 1
infection. Specifically, it is being developed as a component of a 2-drug maintenance regimen
(post-induction of viral suppression) that includes rilpivirine. Rilpivirine requires food
for optimal absorption; therefore the recommended intake of cabotegravir in the planned Phase
3 treatment studies is with food regardless of fat or calorie content, when administered
along with rilpivirine. This is a single-center, randomized, open-label, two-way crossover
study in healthy adult subjects to assess the effect of a high fat meal on the single dose
pharmacokinetics of CAB 30 mg. Approximately, 24 subjects will be enrolled in the study and
will be screened for 30 days. Twelve subjects with at least 10 hours of fasting will be
randomized to receive a single dose of cabotegravir orally (Schedule 'A'). The remaining 12
subjects will receive a single dose of cabotegravir orally along with high fat meal (Schedule
'B'). After 15 days, the subjects earlier undergoing 'Schedule A' will be switched to
'Schedule B' and those undergoing 'Schedule B' will undergo 'Schedule A'. All the subjects
will be followed up to 30 days from the day of receiving first dose of cabotegravir to
evaluate the effect of a high fat meal on the pharmacokinetics of cabotegravir.