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Community-acquired InfectionPhase 1NCT01475695

GSK2251052 Mass Balance in Healthy Adult Subjects

A Phase 1 study testing 14C GSK2251052 in people with Community-acquired Infection, run by GlaxoSmithKline at 1 site in Netherlands.

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

Approximately 6 healthy male subjects will be administered a single 1500 mg intravenous dose of 14C-GSK2251052 under fasted conditions. Blood, urine and fecal samples will be collected for a minimum of 14 days following study drug administration. Safety and tolerability will be monitored throughout the study. 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
Community-acquired Infection
What is being tested?
14C GSK2251052
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteNetherlands
Study dates
21 Apr 2011to 19 May 2011
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 as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Male between 30 and 55 years of age inclusive, at the time of signing the informed consent.
  • Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication through at least 90 days following the dose of GSK2251052.
  • Body weight equal to or greater than 50 kg and BMI within the range 18.5-30.0 kg/m2 (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • QTcB less than 450 msec or QTc less than 480 msec in subjects with Bundle Branch Block.
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  • Available to complete the study and return for follow-up visits if necessary.
  • A history of regular bowel movements (averaging one or more bowel movements per day).
  • AST, ALT, alkaline phosphatase and bilirubin equal to or less than 1.5xULN (isolated bilirubin greater than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).

Who cannot join

  • Female subjects.
  • 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).
  • A positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • A positive test for HIV antibody.
  • History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units for males or greater than14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
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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, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • 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.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
  • 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.
  • Subjects who have received a total body radiation dose of greater than 5.0 mSv (upper limit of WHO category II) or exposure to significant radiation (e.g. serial x-ray or CT scans, barium meal etc) in the 12 months prior to this study.
  • Any condition that could interfere with the accurate assessment and recovery of radioactivity [14C].
  • Participation in a clinical trial involving administration of 14C-labelled compound(s) within the last 12 months.
  • Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy should be excluded.
  • The subject's systolic blood pressure is outside the range of 90-140 mmHg, or diastolic blood pressure is outside the range of 45-90 mmHg or heart rate is outside the range of 45-100 bpm. A single repeat is allowed to determine eligibility.
  • Exclusion criteria for screening ECG per protocol.(a single repeat is allowed for eligibility determination).

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • GSK Investigational Site

    Zuidlaren, 9471 GP

Other trials in Netherlands

About this study

Official title: An Open Label, Non-Randomized, Single Dose, Mass Balance Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK2251052 Administered as a Single Intravenous Dose to Healthy Adult Subjects

Approximately 6 healthy male subjects will be administered a single 1500 mg intravenous dose of 14C-GSK2251052 under fasted conditions. Blood, urine and fecal samples will be collected for a minimum of 14 days following study drug administration. Safety and tolerability will be monitored throughout the study. A follow-up visit will occur 7-14 days after study drug administration.

Being tested
14C GSK2251052
Keywords
Mass balance, intravenous, GSK2251052, Healthy volunteer, Antimicrobial, Radiolabel
Medical subject headings
Community-Acquired Infections

What participants receive

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

  • 14C GSK2251052Drug

    1500 mg iv dose GSK2251052

Study groups in NCT01475695
Study groupRoleWhat they receive
Single cohortExperimental14C GSK2251052
Receives: Drug: 14C GSK2251052

What is being measured

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

  1. Evaluate pharmacokinetic parameters for GSK2251052 and radiolabeled compound following intravenous dose

    Measured: Up to 14 days

  2. Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time

    Measured: Up to 14 days

  3. Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments

    Measured: Up to 14 days

  4. Maximum observed concentration

    Measured: Up to 14 days

  5. Time of occurrence of maximum observed concentration

    Measured: Up to 14 days

  6. Terminal phase half-life

    Measured: Up tp 14 days

  7. Systemic clearance of parent drug

    Measured: Up to 14 days

  8. Volume of distribution

    Measured: Up to 14 days

  9. Percent recovery of total radiocarbon in urine and feces

    Measured: Up to 14 days

  10. Urine, fecal recovery and total recovery of radioactivity (as a percentage of total radioactive dose in each interval and cumulative)

    Measured: Up to 14 days

Secondary outcomes (2)

  1. Adverse events, vital signs, electrocardiogram and clinical laboratory assessments.

    Measured: Up to 14 days

  2. Collection of samples for characterization and quantification, or estimation, of GSK2251052-related metabolites in plasma, urine and fecal homogenates to be conducted under a separate protocol.

    Measured: 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.

  1. First posted21 Nov 2011 (estimated)
  2. Study start21 Apr 2011
  3. Primary completion19 May 2011
  4. Study completion19 May 2011

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01475695
Sponsor's protocol ID
115243
Status last verified
Jun 2017
First submitted
17 Nov 2011
Last updated
28 Jun 2017
Results posted
No
Data monitoring committee
No

Publications

  • Bowers GD, Tenero D, Patel P, Huynh P, Sigafoos J, O'Mara K, Young GC, Dumont E, Cunningham E, Kurtinecz M, Stump P, Conde JJ, Chism JP, Reese MJ, Yueh YL, Tomayko JF. Disposition and metabolism of GSK2251052 in humans: a novel boron-containing antibiotic. Drug Metab Dispos. 2013 May;41(5):1070-81. doi: 10.1124/dmd.112.050153. Epub 2013 Feb 25.

    PubMed 23439661

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 14C GSK2251052 in people with Community-acquired Infection, run by GlaxoSmithKline at 1 site in Netherlands.

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 9 inclusion and 22 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 28 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 Netherlands. 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?

Evaluate pharmacokinetic parameters for GSK2251052 and radiolabeled compound following intravenous dose (time frame: Up to 14 days). The study lists 10 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 NCT01475695, 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 28 Jun 2017.

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