Infections, BacterialPhase 1NCT01610388

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

A Phase 1 study of 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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Infections, Bacterial
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 61 participants
Where: 1 siteUnited States
Study dates: 13 Sep 2011to 26 Jan 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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including [medical history, physical examination, laboratory tests and ECGs. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included at the discretion of the Investigator only if the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the final follow up visit.
Body weight greater than or equal to 50 kilograms and body mass index (BMI) between 18.5-29.9 (inclusive).
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
QTcB less than 450 millisecond (msec); or QTcB less than 480 msec in subjects with Bundle Branch Block on Screening ECG

Who cannot join

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Contraindications to bronchoalveolar lavage including hypercapnia greater than 50 mm Hg, refractory hypoxemia, reactive airway disease or asthma, unstable angina or acute myocardial infarction in the last 6 months, heart failure, and severe hemostatic alterations (Cohort C only).
A positive pre-study drug/alcohol screen.
A positive test for HIV antibody.
History of regular alcohol consumption within 6 months of the study

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The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, and within 5 days following discontinuation of GSK1322322 (for sensitive and narrow therapeutic index CYP3A4 substrates), unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
Use of antacids, H2 blockers, proton pump inhibitors, vitamins, and iron supplements within 7 days prior to the first dose of study medication and for the duration of the trial, including follow-up.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
History of sensitivity to medications used in study, ie Atropine, Midazolam, Fentanyl, Lidocaine, Codeine (Cohort C only) that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Where participation in the study would result in donation of blood or blood products in excess of 500 milliliters within a 56 day period.
Pregnant females as determined by positive [serum or urine] test at screening or prior to dosing.
Lactating females.
Unwillingness or inability to follow the procedures outlined in the protocol.
Subject is mentally or legally incapacitated.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
Consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices] from 7 days prior to the first dose of study medication.
Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination): Heart rate: males less than 45 and greater than 100 beats per minute (bpm) and females less than 50 and greater than 100bpm. PR interval less than 120 and greater than 220msec, QRS duration less than 70 and greater than 120 msec, and QTcB greater than 450msec. Evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization). Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome), sinus pauses> 3 seconds, non-sustained or sustained ventricular tachycardia (greater than or equal to 3 consecutive ventricular ectopic beats) or any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety of the individual subject.

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: A Randomized, Double-Blind, Placebo-Controlled Repeat Dose Escalation, First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

This first time in human (FTIH) study will be the first administration of GSK1322322 as an intravenous formulation and will investigate safety, tolerability, and pharmacokinetics in healthy subjects. One cohort of subjects will undergo bronchoalveolar lavage (BAL) for determination of GSK1322322 concentrations in lung with simultaneous comparison to plasma concentrations to evaluate drug penetration in the lung. The study will evaluate the absolute bioavailability of an oral tablet formulation as compared to the IV formulation.In addition, Amendment 01 will enable the investigation of an improved IV formulation (GSK1322322J mesylate salt) in an additional repeat dosing cohort and the supra-therapeutic cohort.

Conditions: Infections, Bacterial
Being tested: 500mg IV GSK1322322/placebo, 1000mg oral GSK1322322/placebo, 1000mg IV GSK1322322/placebo, 1500mg oral GSK1322322/placebo dose, 1500mg IV GSK1322322/placebo
Keywords: healthy subjects, double-blind, FTIH, dose-escalation, absolute bioavailability, GSK1322322, BAL
Medical subject headings: Bacterial Infections

What participants receive

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

500mg IV GSK1322322/placeboDrug
500mg IV
1000mg oral GSK1322322/placeboDrug
1000mg oral
1000mg IV GSK1322322/placeboDrug
1000mg IV
1500mg oral GSK1322322/placebo doseDrug
1500mg oral
1500mg IV GSK1322322/placeboDrug
1500mg IV
2000mg IV GSK1322322J/placeboDrug
2000mg IV
3000mg IV GSK1322322J/placeboDrug
3000mg IV
1000mg IV GSK1322322J/placeboDrug
1000mg IV

Study groups in NCT01610388
Study group	Role	What they receive
Cohort A1	Experimental	Single dose 60 minute infusion of 500mg IV GSK1322322/placebo followed by BID for 4 days Receives: Drug: 500mg IV GSK1322322/placebo
Cohort A2	Experimental	Single dose 30 minute infusion of 500mg IV GSK1322322/placebo followed by BID for 4 days Receives: Drug: 500mg IV GSK1322322/placebo
Cohort B	Experimental	Initial single 1000mg oral GSK1322322/placebo dose, initial single dose 1000mg IV GSK1322322/placebo followed by BID for 4 days Receives: Drug: 1000mg oral GSK1322322/placebo; Drug: 1000mg IV GSK1322322/placebo
Cohort C	Experimental	Initial single 1500mg oral GSK1322322/placebo dose, initial single dose 1500mg IV GSK1322322/placebo followed by BID for 4 days Receives: Drug: 1500mg oral GSK1322322/placebo dose; Drug: 1500mg IV GSK1322322/placebo
Cohort D	Experimental	Single dose 2000mg IV GSK1322322J/placebo Receives: Drug: 2000mg IV GSK1322322J/placebo
Cohort E	Experimental	Single dose 3000mg IV GSK1322322J/placebo Receives: Drug: 3000mg IV GSK1322322J/placebo
Cohort F	Experimental	1000mg IV GSK1322322J/placebo followed by BID for 4 days Receives: Drug: 1000mg IV GSK1322322J/placebo

What is being measured

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

GSK1322322 safety parameters including the number of subjects with adverse events (AEs)
Measured: Cohort A up to 14 days; Cohort B and C up to 16 days
GSK1322322 safety parameters including absolute values and changes over time of clinical safety laboratory assessments.
Measured: Cohort A up to 14 days; Cohort B and C up to 16 days
GSK1322322 safety parameters including the change from baseline in vital signs (blood pressure (BP) and heart rate)
Measured: Cohort A up to 14 days; Cohort B and C up to 16 days
GSK1322322 safety parameters including change from baseline in electrocardiogram (ECG) parameters
Measured: Cohort A up to 14 days; Cohort B and C up to 16 days
GSK1322322 pharmacokinetic parameters (PK) after single oral dose, area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t)).
Measured: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-∞)).
Measured: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose aximum observed concentration (Cmax).
Measured: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose time of occurrence of Cmax (tmax).
Measured: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose mean residence time (MRTpo)
Measured: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose apparent clearance after oral administration (CL/F)
Measured: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose apparent volume of distribution after oral administration (Vz/F)
Measured: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose terminal phase half-life (t 1/2).
Measured: cohort B and C on Day -2
GSK1322322 PK parameters after single IV dose area under the concentration-time curve from zero (pre-dose) to some fixed nominal time (12 hours) (AUC(0-12)).
Measured: Cohorts A, B, C, D, E on Day 1
GSK1322322 PK parameters after single IV dose area under the concentration-time curve from zero (pre-dose) to some fixed nominal time (24 hours) AUC(0-24)
Measured: Cohorts A, B, C, D, E on Day 1
GSK1322322 PK parameters after single IV dose AUC(0-t)
Measured: Cohorts A, B, C, D, E on Day 1
GSK1322322 PK parameters after single IV dose AUC(0-∞).
Measured: Cohorts A, B, C, D, E on Day 1
GSK1322322 PK parameters after single IV dose Cmax
Measured: Cohorts A, B, C, D, E on Day 1
GSK1322322 PK parameters after single IV dose mean residence time intravenous (MRTiv)
Measured: Cohort A, B, C, D, E on Day 1
GSK1322322 PK parameters after single IV dose t1/2
Measured: Cohort A, B, C, D, E on Day 1
Absolute bioavailability will be determined by comparing oral AUC(0-∞) to IV AUC(0-∞)
Measured: Cohort B and C on Day -2 and Day 1
MAT of oral tablet will be determined (=MRTpo-MRTiv)
Measured: Cohort B and C on Day -2 and Day 1
After repeated IV doses, pharmacokinetic parameters including Area under the concentration-time curve over the dosing interval (AUC(0-τ))
Measured: Cohorts A, B, C on Days 3 - 6
After repeated IV doses, pharmacokinetic parameters including Cmax
Measured: Cohorts A, B, C on Days 3 - 6
After repeated IV doses, pharmacokinetic parameters including CL
Measured: Cohorts A, B, C on Days 3 - 6
GSK1322322 concentrations in BAL obtained in epithelial lining fluid (ELF) and alveolar macrophages (AM) as compared to that in plasma
Measured: Cohort C Day 6

Secondary outcomes (9)

GSK1322322 urine PK parameters: amount excreted (Ae) of unchanged GSK1322322, fraction of the dose excreted in the urine (fe) and renal clearance (CLr) following single dose IV administration from Period 2 and Period 3.
Measured: cohort B and C on Day 1 and 2
Day 6 GSK1322322 AUC(0-τ) compared to AUC(0-12) on Day 1 to evaluate the accumulation ratio following repeat IV administration of GSK1322322.
Measured: Cohorts A, B, C Day 6 and Day 1
Day 6 GSK1322322 AUC(0-τ) compared to AUC(0-∞) on Day 1 to evaluate time invariance following repeat IV administration of GSK1322322.
Measured: Cohorts A, B, C Day 6 and Day 1
GSK1322322 PK parameters: AUC(0-∞) on Day 1 and AUC(0-τ) on Day 6 following IV administration at different doses for the assessment of dose proportionality.
Measured: Cohorts A, B, C Day1 and 6
Microbiome analysis of stool prior to and after exposure to GSK1322322
Measured: Cohort A, B,C, D, E single sample predose and single sample post dose
GSK1322322J safety parameters including the number of subjects with adverse events (AEs)
Measured: Cohort D and E up to 11 days, Cohort F up to 14 days
GSK1322322J safety parameters including absolute values and changes over time of clinical safety laboratory assessments
Measured: Cohort D and E up to 11 days; Cohort F up to 14 days
GSK1322322J safety parameters including the change from baseline in vital signs (blood pressure (BP) and heart rate)
Measured: Cohort D and E up to 11 days; Cohort F up to 14 days
GSK1322322J safety parameters including change from baseline in electrocardiogram (ECG) parameters
Measured: Cohort D and E up to 11 days: Cohort F up to 14 days

Timeline

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

13 Sep 201126 Jan 2012

First posted4 Jun 2012 (estimated)
Study start13 Sep 2011
Primary completion26 Jan 2012
Study completion26 Jan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Other
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01610388
Sponsor's protocol ID: 113376
Status last verified: Jun 2017
First submitted: 31 May 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.

Publications

Naderer OJ, Rodvold KA, Jones LS, Zhu JZ, Bowen CL, Chen L, Dumont E. Penetration of GSK1322322 into epithelial lining fluid and alveolar macrophages as determined by bronchoalveolar lavage. Antimicrob Agents Chemother. 2014;58(1):419-23. doi: 10.1128/AAC.01836-13. Epub 2013 Nov 4.
PubMed 24189245

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?

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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: A Randomized, Double-Blind, Placebo-Controlled Repeat Dose Escalation, First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects
ClinicalTrials.gov ID: NCT01610388
Acronym / sponsor ID: 113376
Conditions: Infections, Bacterial
Keywords: healthy subjects, double-blind, FTIH, dose-escalation, absolute bioavailability, GSK1322322, BAL
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 13 Sep 2011 (actual)
Primary completion: 26 Jan 2012 (actual)
Study completion: 26 Jan 2012 (actual)
First posted: 4 Jun 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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
Cohort A1	Experimental	Drug: 500mg IV GSK1322322/placeboSingle dose 60 minute infusion of 500mg IV GSK1322322/placebo followed by BID for 4 days
Cohort A2	Experimental	Drug: 500mg IV GSK1322322/placeboSingle dose 30 minute infusion of 500mg IV GSK1322322/placebo followed by BID for 4 days
Cohort B	Experimental	Drug: 1000mg oral GSK1322322/placebo, Drug: 1000mg IV GSK1322322/placeboInitial single 1000mg oral GSK1322322/placebo dose, initial single dose 1000mg IV GSK1322322/placebo followed by BID for 4 days
Cohort C	Experimental	Drug: 1500mg oral GSK1322322/placebo dose, Drug: 1500mg IV GSK1322322/placeboInitial single 1500mg oral GSK1322322/placebo dose, initial single dose 1500mg IV GSK1322322/placebo followed by BID for 4 days
Cohort D	Experimental	Drug: 2000mg IV GSK1322322J/placeboSingle dose 2000mg IV GSK1322322J/placebo
Cohort E	Experimental	Drug: 3000mg IV GSK1322322J/placeboSingle dose 3000mg IV GSK1322322J/placebo
Cohort F	Experimental	Drug: 1000mg IV GSK1322322J/placebo1000mg IV GSK1322322J/placebo followed by BID for 4 days

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including [medical history, physical examination, laboratory tests and ECGs. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included at the discretion of the Investigator only if the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the final follow up visit.
Body weight greater than or equal to 50 kilograms and body mass index (BMI) between 18.5-29.9 (inclusive).

Key exclusion criteria (21 listed)

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Contraindications to bronchoalveolar lavage including hypercapnia greater than 50 mm Hg, refractory hypoxemia, reactive airway disease or asthma, unstable angina or acute myocardial infarction in the last 6 months, heart failure, and severe hemostatic alterations (Cohort C only).
A positive pre-study drug/alcohol screen.
A positive test for HIV antibody.

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
500mg IV GSK1322322/placebo500mg IV	Drug	Cohort A1, Cohort A2
1000mg oral GSK1322322/placebo1000mg oral	Drug	Cohort B
1000mg IV GSK1322322/placebo1000mg IV	Drug	Cohort B
1500mg oral GSK1322322/placebo dose1500mg oral	Drug	Cohort C
1500mg IV GSK1322322/placebo1500mg IV	Drug	Cohort C
2000mg IV GSK1322322J/placebo2000mg IV	Drug	Cohort D
3000mg IV GSK1322322J/placebo3000mg IV	Drug	Cohort E
1000mg IV GSK1322322J/placebo1000mg IV	Drug	Cohort F

Primary outcome

GSK1322322 safety parameters including the number of subjects with adverse events (AEs)
Time frame: Cohort A up to 14 days; Cohort B and C up to 16 days
GSK1322322 safety parameters including absolute values and changes over time of clinical safety laboratory assessments.
Time frame: Cohort A up to 14 days; Cohort B and C up to 16 days
GSK1322322 safety parameters including the change from baseline in vital signs (blood pressure (BP) and heart rate)
Time frame: Cohort A up to 14 days; Cohort B and C up to 16 days
GSK1322322 safety parameters including change from baseline in electrocardiogram (ECG) parameters
Time frame: Cohort A up to 14 days; Cohort B and C up to 16 days
GSK1322322 pharmacokinetic parameters (PK) after single oral dose, area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t)).
Time frame: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-∞)).
Time frame: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose aximum observed concentration (Cmax).
Time frame: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose time of occurrence of Cmax (tmax).
Time frame: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose mean residence time (MRTpo)
Time frame: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose apparent clearance after oral administration (CL/F)
Time frame: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose apparent volume of distribution after oral administration (Vz/F)
Time frame: Cohorts B and C on Day -2
GSK1322322 PK parameters after single oral dose terminal phase half-life (t 1/2).
Time frame: cohort B and C on Day -2
GSK1322322 PK parameters after single IV dose area under the concentration-time curve from zero (pre-dose) to some fixed nominal time (12 hours) (AUC(0-12)).
Time frame: Cohorts A, B, C, D, E on Day 1
GSK1322322 PK parameters after single IV dose area under the concentration-time curve from zero (pre-dose) to some fixed nominal time (24 hours) AUC(0-24)
Time frame: Cohorts A, B, C, D, E on Day 1
GSK1322322 PK parameters after single IV dose AUC(0-t)
Time frame: Cohorts A, B, C, D, E on Day 1
GSK1322322 PK parameters after single IV dose AUC(0-∞).
Time frame: Cohorts A, B, C, D, E on Day 1
GSK1322322 PK parameters after single IV dose Cmax
Time frame: Cohorts A, B, C, D, E on Day 1
GSK1322322 PK parameters after single IV dose mean residence time intravenous (MRTiv)
Time frame: Cohort A, B, C, D, E on Day 1
GSK1322322 PK parameters after single IV dose t1/2
Time frame: Cohort A, B, C, D, E on Day 1
Absolute bioavailability will be determined by comparing oral AUC(0-∞) to IV AUC(0-∞)
Time frame: Cohort B and C on Day -2 and Day 1
MAT of oral tablet will be determined (=MRTpo-MRTiv)
Time frame: Cohort B and C on Day -2 and Day 1
After repeated IV doses, pharmacokinetic parameters including Area under the concentration-time curve over the dosing interval (AUC(0-τ))
Time frame: Cohorts A, B, C on Days 3 - 6
After repeated IV doses, pharmacokinetic parameters including Cmax
Time frame: Cohorts A, B, C on Days 3 - 6
After repeated IV doses, pharmacokinetic parameters including CL
Time frame: Cohorts A, B, C on Days 3 - 6
GSK1322322 concentrations in BAL obtained in epithelial lining fluid (ELF) and alveolar macrophages (AM) as compared to that in plasma
Time frame: Cohort C Day 6

9 secondary outcomes

GSK1322322 urine PK parameters: amount excreted (Ae) of unchanged GSK1322322, fraction of the dose excreted in the urine (fe) and renal clearance (CLr) following single dose IV administration from Period 2 and Period 3.
Time frame: cohort B and C on Day 1 and 2
Day 6 GSK1322322 AUC(0-τ) compared to AUC(0-12) on Day 1 to evaluate the accumulation ratio following repeat IV administration of GSK1322322.
Time frame: Cohorts A, B, C Day 6 and Day 1
Day 6 GSK1322322 AUC(0-τ) compared to AUC(0-∞) on Day 1 to evaluate time invariance following repeat IV administration of GSK1322322.
Time frame: Cohorts A, B, C Day 6 and Day 1
GSK1322322 PK parameters: AUC(0-∞) on Day 1 and AUC(0-τ) on Day 6 following IV administration at different doses for the assessment of dose proportionality.
Time frame: Cohorts A, B, C Day1 and 6
Microbiome analysis of stool prior to and after exposure to GSK1322322
Time frame: Cohort A, B,C, D, E single sample predose and single sample post dose
GSK1322322J safety parameters including the number of subjects with adverse events (AEs)
Time frame: Cohort D and E up to 11 days, Cohort F up to 14 days
GSK1322322J safety parameters including absolute values and changes over time of clinical safety laboratory assessments
Time frame: Cohort D and E up to 11 days; Cohort F up to 14 days
GSK1322322J safety parameters including the change from baseline in vital signs (blood pressure (BP) and heart rate)
Time frame: Cohort D and E up to 11 days; Cohort F up to 14 days
GSK1322322J safety parameters including change from baseline in electrocardiogram (ECG) parameters
Time frame: Cohort D and E up to 11 days: Cohort F up to 14 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.
Derived from this study: PubMed 24189245Naderer OJ, Rodvold KA, Jones LS, Zhu JZ, Bowen CL, Chen L, Dumont E. Penetration of GSK1322322 into epithelial lining fluid and alveolar macrophages as determined by bronchoalveolar lavage. Antimicrob Agents Chemother. 2014;58(1):419-23. doi: 10.1128/AAC.01836-13. Epub 2013 Nov 4.
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.
Results for study 113376 can be found on the GSK Clinical Study Register.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.

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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?

A Phase 1 study of Infections, Bacterial, run by GlaxoSmithKline at 1 site in United States.

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 7 inclusion and 21 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?

GSK1322322 safety parameters including the number of subjects with adverse events (AEs) (time frame: Cohort A up to 14 days; Cohort B and C up to 16 days). The study lists 25 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 NCT01610388, which also lists 1 linked publication.

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.