NCT02853435

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Infections, Bacterial

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-08-04
• Primary completion: 2017-10-17
• Completion: 2017-10-17
• First posted: 2016-08-03
• Last updated: 2020-10-08
• Results posted: 2018-11-14

Locations

2 sites across 1 country: United States