Last updated: 11/07/2018 08:27:17

First time in human study using GSK2330672

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GSK study ID
114985
See study documents
Clinicaltrials.gov ID
NCT01416324
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 first time in human, single blind, randomized, placebo-controlled,dose escalating crossover study to evaluate the safety,tolerability, pharmacokinetic and pharmacodynamic parameters of single doses of GSK2330672 in healthy volunteers
Trial description: The purpose of this study is to look at the safety and tolerability of increasing single doses of GSK2330672 in healthy volunteers.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Change in vital signs

Timeframe: 1, 2, 4, 8, 12, 24, 48 hours

ECGs relative to placebo

Timeframe: 1, 2, 4, 8, 12, 24, 48 hours

Changes in clinical lab results

Timeframe: 24 hours

lung function tests

Timeframe: 1, 3, 8, 24 hours

Adverse events relative to placebo

Timeframe: 48 hour monitoring

Secondary outcomes:

Measurement of the maximum concentration (Cmax) for study drug

Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours

Measurement of the time to achieve maximum concentration (tmax) for study drug

Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours

Measurement of area under the curve (AUC) for study drug

Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours

Measurement of half life (t 1/2) of study drug

Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours

Measurement of apparent clearance (CL/F) of the study drug

Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours

Measurement of the apparent volume of distribution (V/F) of the study drug

Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours

Interventions:
Drug: placebo
Drug: 0.1 mg GSK2330672
Drug: 0.3 mg GSK2330672
Drug: 1 mg GSK2330672
Drug: 3 mg GSK2330672
Drug: 10 mg GSK2330672
Drug: 30 mg GSK2330672
Drug: 60 mg GSK2330672
Enrollment:
17
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2
Product
GSK2330672
Collaborators
Not applicable
Study date(s)
June 2011 to September 2011
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
  • healthy volunteer
  • 18-60 yrs of age
  • pregnant or breastfeeding females
  • positive HIV
Inclusion and exclusion criteria
Inclusion criteria:
  • healthy volunteer
  • 18-60 yrs of age -for subjects age 50 and above: negative fecal occult blood test within 3 months prior to expected start of dosing, and normal results from sigmoidoscopy or colonoscopy within 5 yrs prior to dosing.
  • if female, must be of non-childbearing potential
Exclusion criteria:
  • pregnant or breastfeeding females
  • positive HIV -positive Hep B, or Hep C within 3 months of screening -positive drugs of abuse screening
  • triglycerides > 250 mg/dL
  • current or chronic history of liver disease -any gastrointestinal or gastrointestinal related conditions that could affect fat or bile acid reabsorption -pancreatitis
  • colon cancer or 1st degree relative who has had colon cancer -abnormal lung function tests -inability to perform lung function tests -unwilling to abstain from smoking, alcohol, caffeine, illicit drugs as directed by the site staff -exposure to more than 4 new chemical entities in the 12 months prior to the first dosing day. -where participation in the study would results in donation of more than approximately 550mL of blood in a 56-day period.

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
Status
Study Complete
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Study documents

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
2011-09-09

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 114985 can be found on the GSK Clinical Study Register.
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