A Study to Compare the Relative Bioavailability of Two Different Formulations of GSK3640254
Status:
Completed
Trial end date:
2018-08-06
Target enrollment:
Participant gender:
Summary
This is a first time in human (FTIH), 2-period study, to assess the relative bioavailability
of a mesylate salt capsule of GSK3640254, compared to a bis- hydrochloride salt capsule of
GSK3640254, in healthy subjects, administered following a moderate calorie and fat meal. The
subjects will be randomized to 2 sequences, Regimen AB or Regimen BA. For Regimen AB: The
Regimen A, which will include oral administration of GSK3640254 bis-hydrochloride Capsule 200
milligram (mg) (reference), which will be administered, in Period 1 and Regimen B will
include GSK3640254 Mesylate salt capsule (test), 200 mg, which will be administered in Period
2. For the regimen BA, the regimen B, will be administered, in Period 1 and regimen A, in
Period 2. Each of the regimens will be given orally as 2 capsules in the morning, as per
randomization sequence. There will be a minimum washout of 7 days between each dose of study
treatment. A total, of 14 subjects, are planned to be enrolled in the study. The maximum
duration of the study from screening to follow-up is approximately 7 weeks.