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NCT Number: NCT01663389

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

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.

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Key information

Conditions

Infections, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

30 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Minneapolis, Minnesota, 55404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK1322322 1000 mg containing radioactive 14C-GSK1322322

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 containing radioactive 14C-GSK1322322

Drug

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

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

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

    Time frame: Duration of the study (56 days)

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 13, 2012
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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