Last updated: 11/07/2018 03:17:44

Single Dose Escalation First Time in Human PK Study

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GSK study ID
111341
See study documents
Clinicaltrials.gov ID
NCT00828867
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single Dose Escalation First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of Investigational Study Drug in Healthy Subjects
Trial description: This is a first time in human (FTIH) study of single escalating doses of investigational study drug to investigate safety, tolerability, and pharmacokinetics in healthy subjects
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

Safety parameters, adverse events, absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs, electrocardiogram intervals, and ECG rhythm.

Timeframe: Eighteen days

Pharmacokinetic parameters following single dose administration: area under the plasma concentration curve AUC 0 to inf, AUC 0 to t, AUC 0 to 24, maximum observed concentration , time to maximum observed concentration , terminal half life .

Timeframe: Two days, Three days (3000mg and 4000mg only)

Secondary outcomes:

AUC 0 to inf and Cmax following single dose administration for the assessment of dose proportionality

Timeframe: Two days, Three days (3000mg and 4000mg only)

Amount excreted of unchanged study drug and renal clearance

Timeframe: Two days, Three days (3000mg and 4000mg only)

AUC 0 to inf, AUC 0 to t, AUC 0 to 24, Cmax, tmax and tlag if deemed appropriate with and without high fat calorie meal

Timeframe: Two days, Three days (3000mg and 4000mg only)

Interventions:
  • Drug: 100 mg GSK investigational drug
  • Drug: 200 mg GSK investigational drug
  • Drug: 400 mg GSK investigational drug
  • Drug: 800 mg GSK investigational drug
  • Drug: 2000 mg GSK investigational drug
  • Drug: 1500 mg GSK investigational drug
  • Drug: 800mg fed GSK investigational drug
  • Drug: 3000mg GSK investigational drug
  • Drug: 4000mg GSK investigational drug
    • Enrollment:
    41
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Odin J. Naderer, Etienne Dumont, John Zhu, Milena Kurtinecz and Lori S. Jones. Single-dose safety, tolerability, and pharmacokinetics of the antibiotic GSK1322322, a novel peptide deformylase inhibitor. Antimicrob Agents Chemother. 2013;57(5):2005-2009.
    Medical condition
    Infections, Bacterial
    Product
    lanopepden
    Collaborators
    Not applicable
    Study date(s)
    November 2008 to December 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Healthy
    • male
    • The subject has 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 pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy -male -non-childbearling potential females -Body weight greater than or equal to 50 kg (110 lbs) for men and greater than or equal to 45 kg (99 lbs) for women. Body mass index (BMI) between 18.5-29.9 kg/m2 inclusive. -Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form -QTcB < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block on Screening ECG
    Exclusion criteria:
    • The subject has 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 pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. -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 or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). A standard unit is defined as 10g ethanol which is equivalent to 100mL wine, 250mL full strength beer, 470mL light beer, 30mL spirits -The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the 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 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. -Pregnant females as determined by positive [serum or urine] human chorionic gonadotropin (hCG) test at screening or prior to dosing. -Lactating females. -Subjects who have asthma or a history of asthma within the past 6 months. -History of smoking or history of regular use of tobacco- or nicotine-containing products within 3 months prior to screening. -Consumption of red wine, seville oranges, grapefruit or grapefruit juice, pummelos, satsuma, ugli, tangerine, and tangelo, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Randwick, New South Wales, Australia, 2031
    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)

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

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2009-07-12

    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

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    Additional information
    Results for study 111341 can be found on the GSK Clinical Study Register.
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