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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01294566
Registration number
NCT01294566
Ethics application status
Date submitted
3/02/2011
Date registered
11/02/2011
Date last updated
28/06/2017
Titles & IDs
Public title
FTIH to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of GSK1322888 in Healthy Caucasian and Japanese Volunteers
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Scientific title
A Randomized, Placebo Controlled Dose Escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of GSK1322888 in Healthy Caucasian and Japanese Asian Adult Subjects
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Secondary ID [1]
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114422
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastroparesis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GSK1322888
Treatment: Drugs - Placebo
Experimental: Cohort 1 - GSK1322888 (1 mg, 2 mg, 5 mg, 10 mg; 6 subjects) and Placebo (32 subjects)
Experimental: Cohort 2 - GSK1322888 (20 mg, 40 mg, 80 mg, and dose to be determined; 6 subjects) and Placebot (2 subjects)
Treatment: Drugs: GSK1322888
1 mg, 5 mg or 25 mg capsule
Treatment: Drugs: Placebo
matching placebo capsules
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adverse Events following single oral doses of GSK1322888
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Assessment method [1]
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includes abnormal clincal lab values, ECGs, vital signs
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Timepoint [1]
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1 week post dose
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Primary outcome [2]
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pharmacokinetics of GSK1322888 following single, oral doses
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Assessment method [2]
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includes AUC, Cmax, tmax, and t1/2
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Timepoint [2]
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48 h post dose
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Secondary outcome [1]
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gastric emptying of a radio-labeled test meal, as measured by the 13C-octanoic acid breath test following single oral doses of GSK1322888
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Assessment method [1]
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includes gastric half emptying time, gastric emptying coefficient
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Timepoint [1]
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4 h
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Secondary outcome [2]
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dose/exposure response relationship for gastric emptying of a radio-labeled test meal, as measured by the 13C-octanoic acid breath test following single oral doses of GSK1322888
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Assessment method [2]
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dose response of GSK1322888 on gastric emptying
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Timepoint [2]
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48 h
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Secondary outcome [3]
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dose proportionality following single dose administration
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Assessment method [3]
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Timepoint [3]
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48 h
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Secondary outcome [4]
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steady-state PK based on single dose data
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Assessment method [4]
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Timepoint [4]
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28 h
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Secondary outcome [5]
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accumulation based on single dose data
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Assessment method [5]
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Timepoint [5]
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48 h
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Secondary outcome [6]
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ethnicity differences in safety, tolerability, pharmacokinetics, and pharmacodynamics between volunteers of Caucasian or Japanese ethnicity
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Assessment method [6]
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difference in adverse events between ethnicities
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Timepoint [6]
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1 week
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Eligibility
Key inclusion criteria
- AST, ALT, alkaline phosphatase and bilirubin < or =1.5xULN (isolated bilirubin
>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by a responsible and experienced physician
- Male or female between 18 (20 for Japanese) and 65 years of age inclusive
- Male subjects with female partners of child-bearing potential must agree to use one of
the contraception methods
- Body weight > or = 50 kg and BMI within the range 18.5 - 29.9 kg/m2 (inclusive).
- Capable of giving written informed consent
- Average QTc, QTcB or QTcF < 430 msec.
- For Japanese subjects Japanese ancestry defined as being born in Japan, having four
ethnic Japanese grandparents, holding a Japanese passport or identity papers and being
able to speak Japanese.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Hepatitis B or Hepatitis C positive
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- HIV positive
- History of regular alcohol consumption within 6 months of the study
- Exposure to more than four new chemical entities within 12 months prior to the first
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) prior to the first dose of study medication
- History of sensitivity to any of the study medications, or components thereof
- 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
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- Regular use of tobacco- or nicotine-containing products within 6 months prior to
screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or
pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior
to the first dose of study medication.
- Subjects will be screened such that those subjects exhibiting rapid gastric emptying
rates (t½b < 75 min) will be excluded
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/11/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/03/2011
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Sample size
Target
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Accrual to date
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Final
17
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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GSK Investigational Site - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is the First Time In Human study for the motilin receptor agonist, GSK1322888.
GSK1322888 is a potent and selective small molecule motilin receptor agonist, distinct from
the motilide compound structures. The aims of this study are to assess the safety, tolerance,
and pharmacokinetics of single oral doses of GSK1322888 and to identify a well-tolerated and
safe dose that will accelerate gastric emptying of a 13C stable isotope-labeled test meal in
healthy volunteers.
The study will include assessment of ECGs, vital signs, safety laboratory sampling, adverse
events, pharmacokinetics, and the 13C-Octanoic Acid Breath Test to measure gastric emptying.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01294566
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01294566
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