Single Dose Escalation First Time in Human PK Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-14

Study Completion Date

2009-12-07

Brief Summary

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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

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Detailed Description

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Conditions

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Infections, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1

100mg

Group Type EXPERIMENTAL

100 mg GSK investigational drug

Intervention Type DRUG

Cohort 2

200mg

Group Type EXPERIMENTAL

200 mg GSK investigational drug

Intervention Type DRUG

Cohort 3

400mg

Group Type EXPERIMENTAL

400 mg GSK investigational drug

Intervention Type DRUG

Cohort 4

800mg

Group Type EXPERIMENTAL

800 mg GSK investigational drug

Intervention Type DRUG

Cohort 5

1500mg

Group Type EXPERIMENTAL

1500 mg GSK investigational drug

Intervention Type DRUG

Cohort 6

2000mg

Group Type EXPERIMENTAL

2000 mg GSK investigational drug

Intervention Type DRUG

Cohort 7

800mg with food

Group Type EXPERIMENTAL

800mg fed GSK investigational drug

Intervention Type DRUG

Cohort 8

3000mg

Group Type EXPERIMENTAL

3000mg GSK investigational drug

Intervention Type DRUG

Cohort 9

4000mg

Group Type EXPERIMENTAL

4000mg GSK investigational drug

Intervention Type DRUG

Interventions

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100 mg GSK investigational drug

Intervention Type DRUG

200 mg GSK investigational drug

Intervention Type DRUG

400 mg GSK investigational drug

Intervention Type DRUG

800 mg GSK investigational drug

Intervention Type DRUG

2000 mg GSK investigational drug

Intervention Type DRUG

1500 mg GSK investigational drug

Intervention Type DRUG

800mg fed GSK investigational drug

Intervention Type DRUG

3000mg GSK investigational drug

Intervention Type DRUG

4000mg GSK investigational drug

Intervention Type DRUG

Other Intervention Names

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selected mg fed study drug 2000 mg study drug 800 mg study drug 400 mg study drug 200 mg study drug 100 mg study drug 1500 mg study drug

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Randwick, New South Wales, Australia

Site Status

Countries

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Australia

References

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Naderer OJ, Dumont E, Zhu J, Kurtinecz M, Jones LS. Single-dose safety, tolerability, and pharmacokinetics of the antibiotic GSK1322322, a novel peptide deformylase inhibitor. Antimicrob Agents Chemother. 2013 May;57(5):2005-9. doi: 10.1128/AAC.01779-12. Epub 2013 Feb 12.

Reference Type BACKGROUND

PMID: 23403431 (View on PubMed)

Study Documents

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