First Time in Human Study Using GSK2330672
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
1 other identifier
interventional
17
1 country
1
Brief Summary
The purpose of this study is to look at the safety and tolerability of increasing single doses of GSK2330672 in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes-mellitus-type-2
Started Jun 2011
Shorter than P25 for phase_1 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2011
CompletedFirst Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
August 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2011
CompletedJune 20, 2017
June 1, 2017
3 months
June 16, 2011
June 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change in vital signs
frequency and absolute value change in heart rate, blood pressure, respiration rate relative to placebo
1, 2, 4, 8, 12, 24, 48 hours
ECGs relative to placebo
frequency of clinically significant changes in 12-lead ECG parameters relative to placebo
1, 2, 4, 8, 12, 24, 48 hours
Changes in clinical lab results
Changes in clinical chemistry, hematology, urinalysis results relative to placebo
24 hours
lung function tests
Measure changes in FEV, FVC, FEF 25-75%, PEFR relative to placebo
1, 3, 8, 24 hours
Adverse events relative to placebo
Frequency and severity of adverse events relative to placebo
48 hour monitoring
Secondary Outcomes (6)
Measurement of the maximum concentration (Cmax) for study drug
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
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
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
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
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours
- +1 more secondary outcomes
Study Arms (2)
GSK2330672
EXPERIMENTALexperimental study drug
Placebo
PLACEBO COMPARATORplacebo
Interventions
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
Eligibility Criteria
You may qualify if:
- healthy volunteer
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Minneapolis, Minnesota, 55404, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2011
First Posted
August 15, 2011
Study Start
June 15, 2011
Primary Completion
September 9, 2011
Study Completion
September 9, 2011
Last Updated
June 20, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.