Last updated: 11/07/2018 07:42:16

FTIH to evaluate safety, tolerability, and pharmacokinetics of single oral doses of GSK1322888 in healthy caucasian and japanese volunteers

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GSK study ID
114422
See study documents
Clinicaltrials.gov ID
NCT01294566
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Adverse Events following single oral doses of GSK1322888

Timeframe: 1 week post dose

pharmacokinetics of GSK1322888 following single, oral doses

Timeframe: 48 h post dose

Secondary outcomes:

gastric emptying of a radio-labeled test meal, as measured by the 13C-octanoic acid breath test following single oral doses of GSK1322888

Timeframe: 4 h

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

Timeframe: 48 h

dose proportionality following single dose administration

Timeframe: 48 h

steady-state PK based on single dose data

Timeframe: 28 h

accumulation based on single dose data

Timeframe: 48 h

ethnicity differences in safety, tolerability, pharmacokinetics, and pharmacodynamics between volunteers of Caucasian or Japanese ethnicity

Timeframe: 1 week

Interventions:
Drug: GSK1322888
Drug: Placebo
Enrollment:
17
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Gastroparesis
Product
GSK1322888
Collaborators
GSK
Study date(s)
November 2010 to March 2011
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
  • 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
  • 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).
Inclusion and exclusion criteria
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.
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

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Status
Study Complete
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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
Completed
Actual primary completion date
Not applicable
Actual study completion date
2011-23-03

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 114422 can be found on the GSK Clinical Study Register.
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