Diabetes Mellitus, Type 2Phase 1NCT01416324
First Time in Human Study Using GSK2330672
A Phase 1 study testing 0.1 mg GSK2330672, 0.3 mg GSK2330672 and 1 mg GSK2330672 in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this study is to look at the safety and tolerability of increasing single doses of GSK2330672 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- 0.1 mg GSK2330672, 0.3 mg GSK2330672 and 1 mg GSK2330672
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2011to 9 Sep 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Minneapolis, Minnesota, 55404
About this study
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
The purpose of this study is to look at the safety and tolerability of increasing single doses of GSK2330672 in healthy volunteers.
Read the detailed description
This is a single blind, randomized, placebo-controlled, dose escalating, crossover, first time in human study to examine safety, tolerability, pharmacokinetic and pharmacodynamic parameters of GSK233672. Single blind indicates that the subjects and investigator are blinded to treatment but the GSK study team could be unblinded for ongoing review of interim safety data required for dose escalation.
Subjects will participate in 4 dosing periods. Subjects will enter the clinic prior to dinner time on the evening of Day -1 of each period and will remain in residence through the morning of Day 3. Barring any safety or tolerability concerns, subjects will be released at this time provided they have had at least 1 bowel movement after dosing in the clinic.
Subjects will return for their next scheduled dosing period. This process will be repeated for each dosing period. Subjects will return approximately 1 week after check out from their last dosing period for a follow up visit. Subjects will receive standardized meals meeting specific criteria starting with dinner on Day-1 and continuing through Day 1. Standard meals will be provided for the remainder of their stay in the clinic. After an overnight fast, subjects will take their study drug on the morning of Day 1. Dosing will be followed by breakfast and frequent blood sampling to assess pharmacokinetic and pharmacodynamic parameters. Scheduled assessments of heart rate, blood pressure, respiratory rate, ECGs, and clinical laboratories will be obtained to monitor subject safety. Subjects will be connected to cardiac telemetry monitors and will periodically undergo spirometry testing of ventilation parameters. Stool form and frequency of bowel movements will be recorded. All fecal samples will be collected from participants for 48 hours after dosing of study drug, or until they have had at least 1 bowel movement after dosing, whichever occurs first.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- placebo, 0.1 mg GSK2330672, 0.3 mg GSK2330672, 1 mg GSK2330672, 3 mg GSK2330672
- Keywords
- pharmacodynamics, first time in human, pharmacokinetics
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Vehicle used to dilute the powder for oral administration.
0.1 mg GSK2330672Drug
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
0.3 mg GSK2330672Drug
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
1 mg GSK2330672Drug
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
3 mg GSK2330672Drug
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
10 mg GSK2330672Drug
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
30 mg GSK2330672Drug
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
60 mg GSK2330672Drug
GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| GSK2330672 | Experimental | experimental study drug Receives: 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 |
| Placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vital signs
frequency and absolute value change in heart rate, blood pressure, respiration rate relative to placebo
Measured: 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
Measured: 1, 2, 4, 8, 12, 24, 48 hours
Changes in clinical lab results
Changes in clinical chemistry, hematology, urinalysis results relative to placebo
Measured: 24 hours
lung function tests
Measure changes in FEV, FVC, FEF 25-75%, PEFR relative to placebo
Measured: 1, 3, 8, 24 hours
Adverse events relative to placebo
Frequency and severity of adverse events relative to placebo
Measured: 48 hour monitoring
Secondary outcomes (6)
Measurement of the maximum concentration (Cmax) for study drug
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study start15 Jun 2011
- Primary completion9 Sep 2011
- Study completion9 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416324
- Sponsor's protocol ID
- 114985
- Status last verified
- Jun 2017
- First submitted
- 16 Jun 2011
- 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
Karatza E, Swift B, Carreno F, Mukherjee S, Casillas L, Lennie J, Fettiplace J, McLaughlin MM, Kremer AE. Serum bile acid change correlates with improvement in pruritus in patients with primary biliary cholangitis receiving linerixibat. Liver Int. 2024 Sep;44(9):2293-2302. doi: 10.1111/liv.15982. Epub 2024 May 23.
PubMed 38780109
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01416324
- Acronym / sponsor ID
- 114985
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- pharmacodynamics, first time in human, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2011 (actual)
- Primary completion
- 9 Sep 2011 (actual)
- Study completion
- 9 Sep 2011 (actual)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at the safety and tolerability of increasing single doses of GSK2330672 in healthy volunteers.
Detailed description
This is a single blind, randomized, placebo-controlled, dose escalating, crossover, first time in human study to examine safety, tolerability, pharmacokinetic and pharmacodynamic parameters of GSK233672. Single blind indicates that the subjects and investigator are blinded to treatment but the GSK study team could be unblinded for ongoing review of interim safety data required for dose escalation.
Subjects will participate in 4 dosing periods. Subjects will enter the clinic prior to dinner time on the evening of Day -1 of each period and will remain in residence through the morning of Day 3. Barring any safety or tolerability concerns, subjects will be released at this time provided they have had at least 1 bowel movement after dosing in the clinic.
Subjects will return for their next scheduled dosing period. This process will be repeated for each dosing period. Subjects will return approximately 1 week after check out from their last dosing period for a follow up visit. Subjects will receive standardized meals meeting specific criteria starting with dinner on Day-1 and continuing through Day 1. Standard meals will be provided for the remainder of their stay in the clinic. After an overnight fast, subjects will take their study drug on the morning of Day 1. Dosing will be followed by breakfast and frequent blood sampling to assess pharmacokinetic and pharmacodynamic parameters. Scheduled assessments of heart rate, blood pressure, respiratory rate, ECGs, and clinical laboratories will be obtained to monitor subject safety. Subjects will be connected to cardiac telemetry monitors and will periodically undergo spirometry testing of ventilation parameters. Stool form and frequency of bowel movements will be recorded. All fecal samples will be collected from participants for 48 hours after dosing of study drug, or until they have had at least 1 bowel movement after dosing, whichever occurs first.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK2330672 | Experimental | 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 GSK2330672experimental study drug |
| Placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboVehicle used to dilute the powder for oral administration. | Drug | Placebo |
| 0.1 mg GSK2330672GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration. | Drug | GSK2330672 |
| 0.3 mg GSK2330672GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration. | Drug | GSK2330672 |
| 1 mg GSK2330672GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration. | Drug | GSK2330672 |
| 3 mg GSK2330672GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration. | Drug | GSK2330672 |
| 10 mg GSK2330672GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration. | Drug | GSK2330672 |
| 30 mg GSK2330672GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration. | Drug | GSK2330672 |
| 60 mg GSK2330672GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration. | Drug | GSK2330672 |
Primary outcome
Change in vital signs
Time frame: 1, 2, 4, 8, 12, 24, 48 hours
frequency and absolute value change in heart rate, blood pressure, respiration rate relative to placebo
ECGs relative to placebo
Time frame: 1, 2, 4, 8, 12, 24, 48 hours
frequency of clinically significant changes in 12-lead ECG parameters relative to placebo
Changes in clinical lab results
Time frame: 24 hours
Changes in clinical chemistry, hematology, urinalysis results relative to placebo
lung function tests
Time frame: 1, 3, 8, 24 hours
Measure changes in FEV, FVC, FEF 25-75%, PEFR relative to placebo
Adverse events relative to placebo
Time frame: 48 hour monitoring
Frequency and severity of adverse events relative to placebo
6 secondary outcomes
Measurement of the maximum concentration (Cmax) for study drug
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Derived from this study: PubMed 38780109Karatza E, Swift B, Carreno F, Mukherjee S, Casillas L, Lennie J, Fettiplace J, McLaughlin MM, Kremer AE. Serum bile acid change correlates with improvement in pruritus in patients with primary biliary cholangitis receiving linerixibat. Liver Int. 2024 Sep;44(9):2293-2302. doi: 10.1111/liv.15982. Epub 2024 May 23.
- Results for study 114985 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.1 mg GSK2330672, 0.3 mg GSK2330672 and 1 mg GSK2330672 in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.
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 4 inclusion and 14 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 United States. 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. Some participants in this study may receive a placebo. 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?
Change in vital signs (time frame: 1, 2, 4, 8, 12, 24, 48 hours). The study lists 5 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 NCT01416324, 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.