Single Dose Escalation First Time in Human PK Study

NCT00828867 | Completed Phase 1

• 1 other identifier: 111341
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infections, Bacterial

Keywords

healthy subjects; FTIH, single dose, food effect, healthy subjects, double-blind

Outcome Measures

Primary Outcomes (2)

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

  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 .

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

Secondary Outcomes (3)

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

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

• Amount excreted of unchanged study drug and renal clearance

  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

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

Study Arms (9)

Cohort 1

EXPERIMENTAL

100mg

Drug: 100 mg GSK investigational drug

Cohort 2

EXPERIMENTAL

200mg

Drug: 200 mg GSK investigational drug

Cohort 3

EXPERIMENTAL

400mg

Drug: 400 mg GSK investigational drug

Cohort 4

EXPERIMENTAL

800mg

Drug: 800 mg GSK investigational drug

Cohort 5

EXPERIMENTAL

1500mg

Drug: 1500 mg GSK investigational drug

Cohort 6

EXPERIMENTAL

2000mg

Drug: 2000 mg GSK investigational drug

Cohort 7

EXPERIMENTAL

800mg with food

Drug: 800mg fed GSK investigational drug

Cohort 8

EXPERIMENTAL

3000mg

Drug: 3000mg GSK investigational drug

Cohort 9

EXPERIMENTAL

4000mg

Drug: 4000mg GSK investigational drug

Interventions

100 mg GSK investigational drug DRUG

Also known as: 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

Cohort 1

200 mg GSK investigational drug DRUG

Cohort 2

400 mg GSK investigational drug DRUG

Cohort 3

800 mg GSK investigational drug DRUG

Cohort 4

2000 mg GSK investigational drug DRUG

Cohort 6

1500 mg GSK investigational drug DRUG

Cohort 5

800mg fed GSK investigational drug DRUG

Cohort 7

3000mg GSK investigational drug DRUG

Cohort 8

4000mg GSK investigational drug DRUG

Cohort 9

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

Location

Related Publications (1)

• 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.

  PMID: 23403431 BACKGROUND

Related Links

• Results for study 111341 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Bacterial Infections

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: January 26, 2009
• Study Start: November 14, 2008
• Primary Completion: December 7, 2009
• Study Completion: December 7, 2009
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)