Infections, Bacterial Clinical Trial
Official title:
A Three-Part Phase I, Open-Label, Single Ascending Dose, and A Single-Blind, Placebo-Controlled, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Relative Bioavailability of Intravenous and Oral GSK1322322 in Healthy Volunteers and Healthy Male Japanese Subjects
The primary objectives of this study are to assess the safety, tolerability and
pharmacokinetics of GSK1322322 following intravenous (IV) and oral administration. GSK1322322
shows broad spectrum antibacterial activity against pathogens involved in respiratory tract
infections as well as methicillin-resistant S. Aureus (MRSA).
This study consists of three parts (Part A, Part B and Part C). The results from Part A of
this study will enable use of large-scale, commercial tablets produced for administration to
patients in pivotal clinical trials of GSK1322322. The results from Parts B and C will
support enrolment of Japanese subjects in future clinical studies. Additionally, the results
will support the dose selection for further clinical development of GSK1322322 in
hospitalized patients with severe bacterial infections in Japan and other Asian populations.
In Part A, subjects will undergo screening, 4 treatment periods receiving single dose of each
of: 1500 mg Initial, fit-for-purpose tablet (product code AP), 1500 mg Over granulated tablet
(product code AR), and the 1500 mg and 2000 mg of intended commercial tablets (product code
AU).
In Part B of the study subjects will undergo screening, and be randomized to receive 3 doses
of GSK1322322 oral cohort (100 mg, 1500 mg and 2000 mg) or IV cohort (600 mg, 900 mg and 1200
mg) each in 3 treatment periods.
Part C will be a single-blind, placebo-controlled, repeat dose study of GSK1322322 in healthy
Japanese male subjects. GSK1322322 will be administered (fasted) via IV for 4 days BID,
followed by administration of GSK1322322 orally (fed) for 6 days BID. A follow-up evaluation
will be conducted 7-10 days following last dose of for each subjects in each Part of the
study.
Approximately 12 subjects will be enrolled in each part of the study such that approximately
8, 6, and 9 subjects complete dosing and critical assessments in part A,B, and C
respectively.
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