Last updated: 11/07/2018 04:27:44

A study to investigate the recovery, excretion, and pharmacokinetics of 14C -GSK1322322 after an intravenous and an oral dose

Request patient level data
GSK study ID
112167
See study documents
Clinicaltrials.gov ID
NCT01663389
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

Timeframe: 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

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

Secondary outcomes:

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

Timeframe: Duration of the study (56 days)

Interventions:
Drug: GSK1322322 1000 mg containing radioactive 14C-GSK1322322
Drug: GSK1322322 1200 mg containing radioactive 14C-GSK1322322
Enrollment:
5
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Donna Mamaril-Fishman, John Zhu, Min Lin, Clive Felgate, Lori Jones, Patrick Stump, Esaie Pierre, Chester Bowen, Etienne Dumont, Odin Naderer, Parul Patel, Peter D Gorycki, Bo Wen, Liangfu Chen and Yanli Deng.Investigation of Metabolism and Disposition of GSK1322322, a PDF Inhibitor, in Healthy Humans Using Entero-Test®, an Emerging and Promising Device .Drug Metab Dispos.2014;42(8):1314-25
Medical condition
Infections, Bacterial
Product
lanopepden
Collaborators
Not applicable
Study date(s)
August 2012 to October 2012
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
30 - 55 years
Accepts healthy volunteers
Yes
  • 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
  • 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
Inclusion and exclusion 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

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
Status
Study Complete
Contact us

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2012-05-10

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Participate in clinical trial
Additional information
Results for study 112167 can be found on the GSK Clinical Study Register.
Click here
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click here
Access to clinical trial data by researchers
Visit website