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

Primary Purpose

Infections, Bacterial

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

GSK1322322 1000 mg containing radioactive 14C-GSK1322322

GSK1322322 1200 mg containing radioactive 14C-GSK1322322

About this trial

This is an interventional treatment trial for Infections, Bacterial focused on measuring mass balance, radiolabel, oral, IV, GSK1322322, healthy volunteer, antibiotic

Eligibility Criteria

30 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GSK1322322 1000 mg IV

GSK1322322 1200 mg Oral Solution

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Plasma pharmacokinetic (PK) parameters of GSK1322322 and radiolabeled compound following single IV or oral solution dose: AUC(0-infinity), AUC(0-t), Cmax, tmax, t1/2 for IV and oral solution regimens and CL and Vss for IV regimen only

Plasma PK parameters will be statistically summarized by treatment. Plasma concentration-time data will be analyzed by non-compartmental methods. Following PK parameters will be studied: Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)], AUC(0-t), maximum observed concentration (Cmax), time of occurrence of Cmax (tmax), terminal phase half-life (t1/2) for IV and oral solution regimens and systemic clearance (CL) and volume of distribution (Vss) for IV regimen only.

Percent total recovery of radioactivity in urine and feces in each interval and cumulative

Total recovery of radioactivity in urine and feces (as a percentage of total radioactive dose in each interval and cumulative)

Secondary Outcome Measures

Safety parameters including adverse events, clinical laboratory tests, concomitant medications, electrocardiograms, and vital signs

To evaluate the safety and tolerability of GSK1322322 after single IV and oral solution doses in healthy subjects safety parameters will be analyzed.

Full Information

NCT ID

NCT01663389

First Posted

July 19, 2012

Last Updated

June 9, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01663389

Brief Title

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

Official Title

An Open Label, Non-Randomized, Single Dose, Two Period, Cross-Over, Mass Balance Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C -GSK1322322 Administered as a Single Intravenous and Single Oral Dose to Healthy Adult Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

August 10, 2012 (Actual)

Primary Completion Date

October 5, 2012 (Actual)

Study Completion Date

October 5, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections, Bacterial

Keywords

mass balance, radiolabel, oral, IV, GSK1322322, healthy volunteer, antibiotic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK1322322 1000 mg IV

Arm Type

Experimental

Arm Description

Arm Title

GSK1322322 1200 mg Oral Solution

Arm Type

Experimental

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

GSK1322322 1000 mg containing radioactive 14C-GSK1322322

Intervention Description

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

Intervention Name(s)

GSK1322322 1200 mg containing radioactive 14C-GSK1322322

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

Time Frame

Day 1 through Day 8 of Period 1 and Period 2 (16 days)

Title

Percent total recovery of radioactivity in urine and feces in each interval and cumulative

Description

Total recovery of radioactivity in urine and feces (as a percentage of total radioactive dose in each interval and cumulative)

Time Frame

Day 1 through Day 8 (and additional days, if required) of Period 1 and Period 2 (16 days or more)

Secondary Outcome Measure Information:

Title

Safety parameters including adverse events, clinical laboratory tests, concomitant medications, electrocardiograms, and vital signs

Description

To evaluate the safety and tolerability of GSK1322322 after single IV and oral solution doses in healthy subjects safety parameters will be analyzed.

Time Frame

Duration of the study (56 days)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

112167

Available IPD/Information Comments

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

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

112167

Available IPD/Information Comments

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

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

112167

Available IPD/Information Comments

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

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

112167

Available IPD/Information Comments

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

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

112167

Available IPD/Information Comments

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

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

112167

Available IPD/Information Comments

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

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

112167

Available IPD/Information Comments

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

Learn more about this trial

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

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