NCT01818011

A Three-part Study to Determine the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Volunteers and Healthy Male Japanese Subjects

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Infections, Bacterial

Interventions

Type	Name	Description
DRUG	GSK1322322 Initial fit for purpose tablets	Beige, capsule shaped, film-coated tablet with unit dose strength of 500 mg/tablet and dose level of 1500 mg (3 x 500 mg) for single dose oral administration in Part A
DRUG	GSK1322322 over granulated tablets	Light beige, oval shaped, film-coated tablet with unit dose strength of 500 mg/tablet and dose level of 1500 mg (3 x 500 mg) for single dose oral administration in Part A
DRUG	GSK1322322 intended commercial tablets	Light beige, oval shaped, film-coated tablet with unit dose strength of 500 mg/tablet and dose level of 1000 mg (2 x 500),1500 mg (3 x 500 mg) and 2000 mg (4 x 500mg) for single dose oral administration in Part A and B and repeat dose administration twice daily in Part C
DRUG	Placebo tablets	Light beige, oval-shaped, film-coated tablet for repeat dose oral administration (BID for 6 days) in Part C
DRUG	13C-GSK1322322 stable isotope powder	White to slightly colored non-sterile crystalline powder for oral suspension with dose level of 50 mg as a single dose with GSK1322322 tablets in Part A
DRUG	GSK1322322 for injection	White to slightly colored lyophilized powder cake in clear glass vials with unit dose strength of 400 mg/vial and dose levels of 600 mg (1.5 x 400 mg/vial), 900 mg (2.25x400mg/vial), 1200 mg (3x400mg/vial and 1200 mg (3 x 400 mg) for IV administration either as single dose in Part B or as a repeat dose (BID for 4 days) in Part C
DRUG	Placebo injection	A clear and colorless 0.9% Sodium Chloride solution for intravenous administration twice daily for 4 days in Part C

Timeline

• Start date: 2013-08-07
• Primary completion: 2013-10-18
• Completion: 2013-10-18
• First posted: 2013-03-26
• Last updated: 2019-01-15

Locations

1 site across 1 country: United States