NCT01706315

This Study Will Investigate the Safety, Tolerability and Pharmacokinetic Profile of Repeat Oral Doses of GSK2140944 in Healthy Adult Subjects

Completed Phase 1 Last updated 9 May 2017

What this trial tests

Phase 1 trial testing GSK2140944 in Infections, Respiratory Tract in 72 participants. Completed in 13 December 2013.

Timeline

17 October 2012

Primary endpoint
13 December 2013

13 December 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	72
Start date	17 October 2012
Primary completion	13 December 2013
Estimated completion	13 December 2013
Sites	1 location across United States

Drugs / interventions tested

• GSK2140944
• Placebo

Conditions studied

• Infections, Respiratory Tract — all drugs for Infections, Respiratory Tract →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 60, any sex, with Infections, Respiratory Tract. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This will be a randomized, placebo-controlled, single blind study to investigate the safety, tolerability and pharmacokinetic (PK) profile of GSK2140944 following repeat oral doses in healthy adult subjects. The study will include a Screening period (40 days), Treatment period (16 days) and a Follow-up period (26 to 30 days). A single dose will be administered on Day 1 for characterization of single dose PK, followed by twice-daily (BID) or thrice-daily (TID) dosing on Days 3 to 16. Subjects may only be randomized to one cohort per the randomization schedule. Up to 6 cohorts will be enrolled using a sequential panel. Subjects in Cohort 1 will receive GSK2140944 (6) and placebo (2). Subsequent cohorts will enroll 16 subjects such that 12 subjects will receive GSK2140944 and 4 subjects will receive placebo, per dose level according to the randomization schedule. Dose escalations are planned to run in successive weeks. Cohort 2 may begin dosing once subjects in Cohort 1 have completed 7 days of BID dosing, PK data is reviewed and safety data from at least 6 subjects is available. Each subsequent dose escalation will commence only when GSK2140944 safety data and available PK data of at least 12 subjects dosed at the previous dose level have been reviewed. The number of cohorts may be reduced or expanded if needed. The first planned dose is 400 milligram (mg) BID but may be modified based upon emergent PK, safety and tolerability data from ongoing clinical study BTZ115198 evaluating single and repeat intravenous (IV) doses of GSK2140944. The projected dose for Cohort 2 is 800 mg BID, Cohort 3 is 1500 mg BID, Cohort 4 is 2300 mg BID or 1500 mg TID and Cohort 5 and cohort 6 will be decided later. The planned maximum dose is 2500 mg TID but may be modified based upon emergent safety, tolerability and PK data. Doses of GSK2140944 or placebo will be administered following a moderate fat meal.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dose Selection for Phase III Clinical Evaluation of Gepotidacin (GSK2140944) in the Treatment of Uncomplicated Urinary Tract Infections.
   Scangarella-Oman NE, Hossain M, Hoover JL, Perry CR, et al · · 2022 · cited 36× · PMID 34978887 · DOI 10.1128/aac.01492-21
2. Pharmacokinetics, safety, and tolerability of gepotidacin administered as single or repeat ascending doses, in healthy adults and elderly subjects.
   Tiffany C, Dumont EF, Hossain M, Srinivasan M, et al · · 2022 · cited 6× · PMID 35769034 · DOI 10.1111/cts.13359