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

NCT ID: NCT01663389

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-10
• Study Completion Date: 2012-10-05

Brief Summary

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.

Conditions

Infections, Bacterial

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GSK1322322 1000 mg IV

On Day 1 of Period 1, after an overnight fast, subjects will receive GSK1322322 1000 mg IV single dose (containing approximately 45.5 microcurie \[μCi\] radioactive 14C-GSK1322322) for intravenous infusion over 60 minutes.

Group Type: EXPERIMENTAL

GSK1322322 1000 mg containing radioactive 14C-GSK1322322

Intervention Type: DRUG

GSK1322322 1000 mg is a mesylate salt powder for injection containing 45.5 μCi radioactive 14C-GSK1322322 1000 mg as free base.

GSK1322322 1200 mg Oral Solution

On Day 1 of Period 2, after an overnight fast, subjects will receive GSK1322322 1200 mg oral solution single dose (containing approximately 54.5 μCi radioactive 14C-GSK1322322).

Group Type: EXPERIMENTAL

GSK1322322 1200 mg containing radioactive 14C-GSK1322322

Intervention Type: DRUG

GSK1322322 1200 mg is a mesylate salt powder for oral solution containing 54.5 μCi radioactive 14C-GSK1322322 1200 mg as free base.

Interventions

GSK1322322 1000 mg containing radioactive 14C-GSK1322322

GSK1322322 1000 mg is a mesylate salt powder for injection containing 45.5 μCi radioactive 14C-GSK1322322 1000 mg as free base.

Intervention Type: DRUG

GSK1322322 1200 mg containing radioactive 14C-GSK1322322

GSK1322322 1200 mg is a mesylate salt powder for oral solution containing 54.5 μCi radioactive 14C-GSK1322322 1200 mg as free base.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects between 30 and 55 years of age, with body weight between 60 to 80 kilograms (kg) and a history of regular bowel movements
• Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods from first dose of study medication until the final follow up visit
• Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin =<1.5x upper limit of normal
• QT interval by Bazett's correction formula (QTcB) <450 millisecond (msec); or QTcB <480 msec in subjects with Bundle Branch Block
• Available to complete the study and return for follow-up visits if necessary
• Capable of giving written informed consent

Exclusion Criteria

• Any condition that could interfere with the accurate assessment and recovery of radioactivity [14C]
• Participation in a clinical trial involving administration of radiolabeled 14C-labelled compound(s) within the last 12 months
• Any condition which impairs the absorption, distribution, metabolism or excretion of the investigational product
• Subjects with a history of cholecystectomy
• Subject has received a total body radiation dose of greater than 5.0 millisievert (mSv) or exposure to significant radiation during 1 year before dosing
• The subject has a positive: drug/alcohol, Hepatitis, HIV screen
• Abuse of alcohol
• History of liver disease, or known hepatic or biliary abnormalities
• The subject has recently received an investigational product
• Donation of more than 500 mL blood within a 56 day period
• Unwillingness or inability to follow the procedures outlined in the protocol
• Use of prescription or non-prescription drugs
• Subject is mentally or legally incapacitated
• History of sensitivity to heparin or heparin-induced thrombocytopenia
• Smoking or history or regular use of tobacco or nicotine-containing products
• Unable to refrain from consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose
• History of cardiac disease

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Minneapolis, Minnesota, United States

Countries

United States

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

112167

Identifier Type: -

Identifier Source: org_study_id