NCT02058407

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Food Effect of Single or Repeat Doses of GSK2793660 in Healthy Subjects

A Randomised, Double-blind (Sponsor Unblind), Placebo-controlled, Two Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single or Repeat Doses of GSK2793660 in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is the first administration of GSK2793660 to humans and will evaluate the safety, tolerability, PK and PD of single oral ascending doses of GSK2793660, and of repeat oral doses of GSK2793660 in healthy subjects. The study will comprise two parts (Part A and Part B). Part A will consist of two cohorts of subjects, each taking part in a three-way cross over study, with ascending doses of GSK2793660 and placebo. Available safety, PK and PD data will be reviewed before each dose escalation. This will be followed by a food-effect arm in the cohort that received what is deemed to be the target clinical dose. Part B is planned to consist of up to two cohorts of subjects, each taking part in one 14 day repeat dose study period. Subjects will be dosed on Day 1 and then on Days 3-15. It is planned that two doses will be evaluated. The dose(s) to be tested will be selected based on safety, PK, and PD from Part A. The study is intended to provide sufficient confidence in the safety profile of the molecule and information on target engagement to allow progression to further studies.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DRUG	GSK2793660 solution	Clear, colourless solution at a unit dose strength of 0.1 mg/mL, in a glass bottle
DRUG	GSK2793660 capsule	Size zero swedish orange capsule at a unit dose of 3 mg, 10 mg, 20 mg and 50 mg
DRUG	Placebo solution	Matching placebo to GSK2793660 solution
DRUG	Placebo capsule	Matching placebo to GSK2793660 capsule

Timeline

• Start date: 2014-01-28
• Primary completion: 2014-10-31
• Completion: 2014-10-31
• First posted: 2014-02-10
• Last updated: 2018-09-13

Locations

1 site across 1 country: United Kingdom