Infections, BacterialPhase 1NCT01663389

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

A Phase 1 study testing GSK1322322 1000 mg containing radioactive 14C-GSK1322322 and GSK1322322 1200 mg containing radioactive 14C-GSK1322322 in people with Infections, Bacterial, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 30 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Infections, Bacterial
What is being tested?: GSK1322322 1000 mg containing radioactive 14C-GSK1322322 and GSK1322322 1200 mg containing radioactive 14C-GSK1322322
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 10 Aug 2012to 5 Oct 2012
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Minneapolis, Minnesota, 55404

Other trials in United States

About this study

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

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
Being tested: GSK1322322 1000 mg containing radioactive 14C-GSK1322322, GSK1322322 1200 mg containing radioactive 14C-GSK1322322
Keywords: mass balance, radiolabel, oral, IV, GSK1322322, healthy volunteer, antibiotic
Medical subject headings: Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK1322322 1000 mg containing radioactive 14C-GSK1322322Drug
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 containing radioactive 14C-GSK1322322Drug
GSK1322322 1200 mg is a mesylate salt powder for oral solution containing 54.5 μCi radioactive 14C-GSK1322322 1200 mg as free base.

Study groups in NCT01663389
Study group	Role	What they receive
GSK1322322 1000 mg IV	Experimental	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. Receives: Drug: GSK1322322 1000 mg containing radioactive 14C-GSK1322322
GSK1322322 1200 mg Oral Solution	Experimental	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). Receives: Drug: GSK1322322 1200 mg containing radioactive 14C-GSK1322322

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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.
Measured: Duration of the study (56 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 20125 Oct 2012

First posted13 Aug 2012 (estimated)
Study start10 Aug 2012
Primary completion5 Oct 2012
Study completion5 Oct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Infections, BacterialStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01663389
Sponsor's protocol ID: 112167
Status last verified: Jun 2017
First submitted: 19 Jul 2012
Last updated: 12 Jun 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01663389
Acronym / sponsor ID: 112167
Conditions: Infections, Bacterial
Keywords: mass balance, radiolabel, oral, IV, GSK1322322, healthy volunteer, antibiotic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 10 Aug 2012 (actual)
Primary completion: 5 Oct 2012 (actual)
Study completion: 5 Oct 2012 (actual)
First posted: 13 Aug 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
GSK1322322 1000 mg IV	Experimental	Drug: GSK1322322 1000 mg containing radioactive 14C-GSK1322322On 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.
GSK1322322 1200 mg Oral Solution	Experimental	Drug: GSK1322322 1200 mg containing radioactive 14C-GSK1322322On 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).

Who may qualify

Ages: 30 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK1322322 1000 mg containing radioactive 14C-GSK1322322GSK1322322 1000 mg is a mesylate salt powder for injection containing 45.5 μCi radioactive 14C-GSK1322322 1000 mg as free base.	Drug	GSK1322322 1000 mg IV
GSK1322322 1200 mg containing radioactive 14C-GSK1322322GSK1322322 1200 mg is a mesylate salt powder for oral solution containing 54.5 μCi radioactive 14C-GSK1322322 1200 mg as free base.	Drug	GSK1322322 1200 mg Oral Solution

Primary outcome

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
Time frame: Day 1 through Day 8 of Period 1 and Period 2 (16 days)
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
Time frame: Day 1 through Day 8 (and additional days, if required) of Period 1 and Period 2 (16 days or more)
Total recovery of radioactivity in urine and feces (as a percentage of total radioactive dose in each interval and cumulative)

1 secondary outcome

Safety parameters including adverse events, clinical laboratory tests, concomitant medications, electrocardiograms, and vital signs
Time frame: Duration of the study (56 days)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
Results for study 112167 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Infections, Bacterial

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A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Day 1 through Day 8 of Period 1 and Period 2 (16 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01663389.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.