NCT02663089

A Phase 1 (Ph1), Single Dose (SD), GSK961081 Absorption, Distribution, Metabolism, and Excretion (ADME) Study in Healthy Subjects

An Open-label Study in Healthy Male Subjects, to Determine the Excretion Balance and Pharmacokinetics of [14C]-GSK961081, Administered as a Single Intravenous Microtracer (Concomitant With an Inhaled Non-radiolabelled Dose) and a Single Oral Dose

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: Male
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Batefenterol (GSK961081) is a bifunctional bronchodilator that is being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). Absorption, metabolism and excretion of batefenterol have been studied in animals, in vitro, and in previous clinical studies; however, the elimination routes and metabolic pathways of batefenterol have not been fully elucidated in humans. This is an open-label, single centre, non-randomised, 2-period single-sequence crossover, mass balance study to determine total radioactivity (drug related material) in plasma, the rate and extent of excretion of total radioactivity in urine and faeces and the total recovery of radioactivity of \[14C\] GSK961081 administered as a single IV dose (concomitant with an inhaled non-radiolabelled dose) and a single oral dose, in healthy male subjects. A total of 6 healthy male subjects will be enrolled. The duration of each subject in the study is up to 11 weeks, which consists of a screening visit, 2 Treatment Periods, and a follow up visit.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	[14C]-GSK961081 solution for IV infusion	Subjects will receive 10 mL of solution equivalent to 4 mcg of \[14C\]-GSK961081 (approximately 6.2 kilobecquerel \[kBq\]) intravenously as a single dose over 1 hour.
DRUG	[14C]-GSK961081 oral solution	Subjects will receive 10 mL of solution equivalent to 200 mcg of \[14C\]-GSK961081 (approximately 311 kBq) orally as a single dose with up to 250 mL of water.
DRUG	GSK961081 dry powder for inhalation	Subjects will receive single dose of 4 actuations of 300 mcg GSK961081 per actuation (1200 mcg GSK961081 total) as inhalation immediately after the start of infusion.

Timeline

• Start date: 2016-02-08
• Primary completion: 2016-03-17
• Completion: 2016-03-17
• First posted: 2016-01-26
• Last updated: 2021-10-06

Locations

1 site across 1 country: United Kingdom