NCT01663389

A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C -GSK1322322 After an Intravenous and an Oral Dose

Completed Phase 1 Last updated 12 June 2017

What this trial tests

Phase 1 trial testing GSK1322322 1000 mg containing radioactive 14C-GSK1322322 in Infections, Bacterial in 5 participants. Completed in 5 October 2012.

Timeline

10 August 2012

Primary endpoint
5 October 2012

5 October 2012

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	10 August 2012
Primary completion	5 October 2012
Estimated completion	5 October 2012
Sites	1 location across United States

Drugs / interventions tested

• GSK1322322 1000 mg containing radioactive 14C-GSK1322322 — full drug profile →
• GSK1322322 1200 mg containing radioactive 14C-GSK1322322 — full drug profile →

Conditions studied

• Infections, Bacterial — all drugs for Infections, Bacterial →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 30 to 55, male only, with Infections, Bacterial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 1, non-randomized, open label, single-dose, two-period, cross-over study. This study will utilize 14C radiolabeled GSK1322322 to investigate the recovery, excretion, and pharmacokinetics of GSK1322322 in 6 healthy adult male subjects through the sampling of blood, urine, and feces.

Each subject will participate in the study for approximately 7 to 8 weeks i.e., 30 day screening period, two dosing periods (approximately 8 days each) and a follow up visit.

The subjects will be admitted to the clinical unit on Day 1 of the first treatment period and remain in the unit for up to approximately 16 days through the end of the second treatment period.

On Day 1 of Period 1, each subject will receive 14C radiolabeled GSK1322322 as a single therapeutic intravenous (IV) dose (1000 milligrams \[mg\]). When the total radioactivity is \<1% of the administered dose in all subjects, Period 2 dosing will begin (approximately 8 days after the IV dose). On Day 1 of Period 2, each subject will receive single therapeutic oral solution dose (1200 mg). Blood, urine, bile and fecal samples will be collected during both the periods. The subject may be discharged from the unit as early as Day 8 of Period 2. Subjects will visit the study unit for the follow-up visit 7 to 10 days following discharge from the unit.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.