To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

August 4, 2016

Primary Completion Date

October 17, 2017

Study Completion Date

October 17, 2017

Conditions
Infections, Bacterial
Interventions
DRUG

Gepotidacin RC Tablet

The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.

DRUG

Gepotidacin HSWG Tablet

The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.

DRUG

Gepotidacin Capsule

It is a pink gelatin size 00 capsule with no identifying markings containing slightly agglomerated pale yellow to grayish yellow to yellowish gray powder. This is an immediate release capsules containing gepotidacin 500 mg (mesylate salt) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing capsules.

Trial Locations (2)

78744

GSK Investigational Site, Austin

92801

GSK Investigational Site, Anaheim

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY