Infections, Bacterial Clinical Trial
Official title:
A Phase I; Multi-Center; Open-Label (Parts 1 and 2); Randomized, Double-Blind, Placebo-Controlled (Part 3); Single-Dose; 3-Part Study to Evaluate the Relative Bioavailability of Three Formulations in Healthy Subjects, Food Effect on Tablet Formulation in Healthy Subjects, and Pharmacokinetics of Gepotidacin (GSK2140944) in Japanese Subjects in Fasted and Fed States
This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety,
tolerability, and relative bioavailability of the 2 free base tablet formulations (roller
compacted [RC] and high shear wet granulation [HSWG]) compared to the reference capsule
formulation under fasted conditions. This is a 3-period; cross-over study that will guide
which gepotidacin formulation will be used for future studies. Following review of
pharmacokinetic (PK) and safety data in Part 1a, a decision will be made whether to proceed
with Parts 1b and 2.
Part 1b is a 2-period, cross-over study and will assess the effect of food on the PK of the
selected gepotidacin tablet formulation from Part 1a. In Part 2, the PK of the selected
gepotidacin tablet formulation from Part 1a in Japanese (2a) and Chinese (2b) subjects will
be evaluated under fasted conditions.
The duration of the study (from Screening to the Follow-up visit) will be approximately 44
days (Part 1a), 41 days (Part 1b) and 38 days (Part 2a and 2b each), respectively. The
approximate number of subjects enrolled in Part 1a will be 27 (9 subjects in each of the 3
treatment sequences), 16 in Part 1b (8 subjects in each of the 2 treatment sequences) and 12
Japanese and 12 Chinese subjects in Part 2a and 2b, respectively.
n/a
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