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AzTrials

Infections, BacterialPhase 1NCT00828867

Single Dose Escalation First Time in Human PK Study

A Phase 1 study testing 100 mg GSK investigational drug, 200 mg GSK investigational drug and 400 mg GSK investigational drug in people with Infections, Bacterial, run by GlaxoSmithKline at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Infections, Bacterial
What is being tested?
100 mg GSK investigational drug, 200 mg GSK investigational drug and 400 mg GSK investigational drug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteAustralia
Study dates
14 Nov 2008to 7 Dec 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
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  • 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 locations and contacts

1 site in 1 country.

Australia1 site

  • GSK Investigational Site

    Randwick, New South Wales, 2031

Other trials in Australia

About this study

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

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

Being tested
100 mg GSK investigational drug, 200 mg GSK investigational drug, 400 mg GSK investigational drug, 800 mg GSK investigational drug, 2000 mg GSK investigational drug
Keywords
healthy subjects, FTIH, single dose, food effect, healthy subjects, double-blind
Medical subject headings
Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 100 mg GSK investigational drugDrug

    Also called selected mg fed study drug, 2000 mg study drug, 800 mg study drug, 400 mg study drug

  • 200 mg GSK investigational drugDrug

  • 400 mg GSK investigational drugDrug

  • 800 mg GSK investigational drugDrug

  • 2000 mg GSK investigational drugDrug

  • 1500 mg GSK investigational drugDrug

  • 800mg fed GSK investigational drugDrug

  • 3000mg GSK investigational drugDrug

  • 4000mg GSK investigational drugDrug

Study groups in NCT00828867
Study groupRoleWhat they receive
Cohort 1Experimental100mg
Receives: Drug: 100 mg GSK investigational drug
Cohort 2Experimental200mg
Receives: Drug: 200 mg GSK investigational drug
Cohort 3Experimental400mg
Receives: Drug: 400 mg GSK investigational drug
Cohort 4Experimental800mg
Receives: Drug: 800 mg GSK investigational drug
Cohort 5Experimental1500mg
Receives: Drug: 1500 mg GSK investigational drug
Cohort 6Experimental2000mg
Receives: Drug: 2000 mg GSK investigational drug
Cohort 7Experimental800mg with food
Receives: Drug: 800mg fed GSK investigational drug
Cohort 8Experimental3000mg
Receives: Drug: 3000mg GSK investigational drug
Cohort 9Experimental4000mg
Receives: Drug: 4000mg GSK investigational drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Eighteen days

  2. 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 .

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

Secondary outcomes (3)

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

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

  2. Amount excreted of unchanged study drug and renal clearance

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

  3. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2009 (estimated)
  2. Study start14 Nov 2008
  3. Primary completion7 Dec 2009
  4. Study completion7 Dec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00828867
Sponsor's protocol ID
111341
Status last verified
Jun 2017
First submitted
8 Dec 2008
Last updated
20 Jun 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 23403431

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 100 mg GSK investigational drug, 200 mg GSK investigational drug and 400 mg GSK investigational drug in people with Infections, Bacterial, run by GlaxoSmithKline at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety parameters, adverse events, absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs, electrocardiogram intervals, and ECG rhythm. (time frame: Eighteen days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00828867, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.

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