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Diabetes Mellitus, Type 2Phase 1NCT00607906

First-Time-in-Humans Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of SB756050

A Phase 1 study testing SB-756050 immediate release capsule and SB-756050 modified release capsule in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will use single escalating doses of SB756050 to assess safety, pharmacokinetics, and pharmacodynamics in healthy volunteers and in subjects with Type 2 Diabetes Mellitus. 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?
SB-756050 immediate release capsule and SB-756050 modified release capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteUnited States
Study dates
16 Nov 2007to 10 Mar 2008
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 Subjects
  • Healthy male or female subject as determined by a responsible physician, based on a medical evaluation including history, physical examination, vitals signs, laboratory tests, and cardiac monitoring.
  • Female subjects must be of non-childbearing potential including pre-menopausal women with documented (medical report verification) hysterectomy, tubal ligation, or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
  • 18 - 60 years of age, inclusive, at the time of signing and dating the informed consent.
  • BMI (body mass index) within the range 20-30 kg/m2, inclusive.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
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  • Diabetic Subjects
  • Male or female subjects, 18 - 60 years of age, inclusive, at the time of signing the informed consent
  • Female subjects must be of non-childbearing potential including pre-menopausal women with documented (medical report verification) hysterectomy, tubal ligation, or double oophorectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
  • Subjects should have no significant known medical conditions other than T2DM.
  • BMI (body mass index) within the range 25-35 kg/m2, inclusive.
  • T2DM diagnosed at least 3 months prior to Screening with
  • Fasting plasma glucose (FPG) level ≤ 220mg/dL at the Screening visit,
  • FPG level ≤ 250 mg/dL on Day -1 of Period 1
  • For subjects taking no antidiabetic medications: HbA1c between 7 and 10%, inclusive, at Screening visit
  • For subjects taking metformin or a sulfonylurea: HbA1c between 6.5 and 9.5%, inclusive, at Screening visit
  • Subjects must be taking either no anti-diabetic medication, or metformin as monotherapy, or a sulfonylurea as monotherapy. (Subjects taking BOTH metformin and a sulfonylurea are not qualified for the trial). If taking metformin or a sulfonylurea, the dose must have been stable for at least 3 months prior to screening, and the subject must be willing to wash out from metformin or sulfonylureas from Day -7 prior to Period 1, through discharge from Period 4.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Who cannot join

  • As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
  • Has any of the following laboratory abnormalities:
  • Positive pre-study Hepatitis B surface antigen, positive Hepatitis C, or HIV result.
  • History of uncorrected thyroid dysfunction or an abnormal thyroid function test assessed by TSH at Screening
  • A positive pre-study drug/urine screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • A pre-study urine cotinine screen indicating use of tobacco/ nicotine containing products.
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  • Has a history of any gastrointestinal or hepatic conditions that could impact absorption of the investigational compound.
  • Has QTc at Screening > 450 msec. Note that if the initial QTc value is prolonged, the ECG should be repeated two more times (with 5 minutes between ECG readings) and the average of the 3 QTc values used to determine eligibility.
  • Has clinically significant rhythm abnormalities identified during 24-hour Screening Holter assessment.
  • History of regular alcohol consumption averaging >7 drinks/week for women or >14 drinks/week for men. One drink is equivalent to 12 g alcohol (which equals 5 ounces (150 mL) of wine, 12 ounces (360 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening.
  • Smoked or used tobacco or nicotine-containing products within the previous 6 months.
  • Has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
  • 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 5 half-lives (whichever is longer) prior to the first dose of study medication. Acetaminophen may be used as needed for adverse events; however, use should be restricted to 4 hours after dosing if possible with a preferred maximum dose of 2 grams in 24 hours.
  • Unwilling to abstain from
  • Caffeine-or xanthine-containing products for 24 hours prior to dosing until the final post-dose assessment at each treatment level.
  • Use of illicit drugs
  • Alcohol for 24 hours prior to dosing until final post-dose assessment at each treatment level.
  • Consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until collection of the final pharmacokinetic and pharmacodynamic blood samples.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. This includes sensitivity to heparin, if heparin will be used to maintain catheter patency.
  • Where participation in the study would result in donation of blood in excess of 500 mL within a 56 day period.
  • Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study.
  • Healthy Subjects
  • As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
  • Has any of the following laboratory abnormalities:
  • Positive pre-study Hepatitis B surface antigen, positive Hepatitis C, or HIV result.
  • History of uncorrected thyroid dysfunction or an abnormal thyroid function test assessed by TSH at Screening. (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least 3 months prior to Screening and who have a screening thyroid stimulating hormone (TSH) within the normal range may participate.)
  • ALT and/or AST > 2 times the upper limit of normal at screening or prior to the first dose.
  • Fasting triglycerides > 450mg/dL at screening or prior to the first dose.
  • Total Bilirubin > 1.5 times the upper limit of normal at screening or prior to the first dose
  • A positive pre-study drug/urine screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • A pre-study urine cotinine screen indicating use of tobacco/ nicotine containing products.
  • Significant renal disease or loss of a kidney
  • Significant ECG abnormalities,
  • Systolic pressure > 150 mmHg or <80 mmHg or diastolic blood pressure > 95 mmHg or <60 mmHg at screening. Blood pressure assessments may be repeated once if needed, allowing adequate time for subject to rest.
  • Previous use of insulin as a treatment within 3 months of Screening, or for >2 weeks when used for acute illness in the last 12 months prior to Screening, or if used for more than 1 year when associated with GDM.
  • Has a history of any of the following conditions:
  • Clinically significant symptoms of gastroparesis
  • Cholelithiasis or obstructive or inflammatory gallbladder disease within 3 months prior to Screening
  • Gastrointestinal disease that could affect fat or bile acid absorption, including inflammatory bowel disease, chronic diarrhea, Crohn's or malabsorption syndromes within the past year
  • Gastrointestinal surgery
  • Chronic or acute pancreatitis
  • History of regular alcohol consumption averaging >7 drinks/week for women or >14 drinks/week for men. 1 drink is equivalent to (12 g alcohol) = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening.
  • Smoked or used tobacco or nicotine-containing products within the previous 6 months.
  • Has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Is taking prohibited medications:
  • Acetaminophen may be used as needed for adverse events; however, use should be restricted to 4 hours after dosing if possible with a preferred maximum dose of 2 grams in 24 hours.
  • The use of anti-diabetic agents other than metformin or sulfonylureas is reason for exclusion and subjects will not be allowed to wash off of unapproved anti-diabetic medications in order to qualify for participation in this study. Subjects taking BOTH metformin and a sulfonylurea are not qualified for the trial.
  • Subjects must wash out from the following medications during the 7-day period prior to first dose, and must remain off these medications through discharge from period 4: metformin, sulfonylureas, statins, fat absorption blocking agents, bile acid sequestrants
  • All other prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) are prohibited within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication and through discharge from Period 4.
  • Unwilling to abstain from
  • Caffeine-or xanthine-containing products for 24 hours prior to dosing until the final post-dose assessment at each treatment level
  • Use of illicit drugs
  • Alcohol for 24 hours prior to dosing until final post-dose assessment at each treatment level
  • Consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until collection of the final pharmacokinetic and pharmacokinetic blood samples
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. This includes sensitivity to heparin, if heparin will be used to maintain catheter patency.
  • Where participation in the study would result in donation of blood in excess of 500 mL within a 56 day period.
  • Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Minneapolis, Minnesota, 55404

Other trials in United States

About this study

Official title: A Single-blinded, Randomized, Placebo-controlled, Staggered-parallel, Escalating Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered SB756050 in Healthy Volunteers and in Subjects With Type 2 Diabetes Mellitus

This study will use single escalating doses of SB756050 to assess safety, pharmacokinetics, and pharmacodynamics in healthy volunteers and in subjects with Type 2 Diabetes Mellitus.

Being tested
SB-756050 immediate release capsule, SB-756050 modified release capsule, Placebo
Keywords
safety, pharmacodynamics, diabetes, pharmacokinetics
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SB-756050 immediate release capsuleDrug

    SB-756050 immediate release capsules will be size 0, white, opaque capsules with no identifying markings, containing white to off-white drug layered pellets. Each capsule will contain 5, 25 or 100 milligrams of SB-756050.

  • SB-756050 modified release capsuleDrug

    SB-756050 modified release capsules will be size 0, white, opaque capsules with no identifying markings, containing white to off-white enteric coated drug layered pellets. Each capsule will contain either 25or 100 milligrams of SB-756050.

  • PlaceboDrug

    Subjects will also receive placebo capsules.

Study groups in NCT00607906
Study groupRoleWhat they receive
Subjects receiving treatment in cohort A1ExperimentalEligible subjects will receive oral immediate release capsules of SB-756050 with doses of 5 milligrams, 15 milligrams, 50 milligrams, or 100 milligrams.
Receives: Drug: SB-756050 immediate release capsule; Drug: Placebo
Subjects receiving treatment in cohort A2ExperimentalEligible subjects will receive oral immediate release capsules of SB-756050 with doses of 100 milligrams, 200 milligrams, 300 milligrams, or 400 milligrams.
Receives: Drug: SB-756050 immediate release capsule; Drug: Placebo
Subjects receiving treatment in cohort A3ExperimentalEligible subjects will receive oral immediate release capsules of SB-756050 with a dose of 150 milligrams. Subjects will also receive oral modified release capsules of SB-756050 with doses of 150 milligrams, 300 milligrams, or 400 milligrams.
Receives: Drug: SB-756050 immediate release capsule; Drug: SB-756050 modified release capsule; Drug: Placebo
Subjects receiving treatment in cohort A4ExperimentalEligible subjects will receive SB-756050 in this additional cohort.
Receives: Drug: SB-756050 immediate release capsule; Drug: Placebo
Subjects receiving treatment in cohort B1ExperimentalEligible subjects will receive oral modified release capsules of SB-756050 with doses of 50 milligrams, 150 milligrams or 400 milligrams. Subjects will also receive immediate release oral capsules of SB-756050 with a dose of 150 milligrams.
Receives: Drug: SB-756050 immediate release capsule; Drug: SB-756050 modified release capsule; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. adverse events:

    Measured: each visit

  2. clinical laboratory:

    Measured: day -1, day 2 each period

  3. electrocardiogram (ECG):

    Measured: day 1 each period

  4. vital signs assessments:

    Measured: day -1, day 1 each period

Secondary outcomes (3)

  1. plasma drug concentrations:

    Measured: Day 1 each dosing level

  2. plasma blood sugar & other parameter concentrations:

    Measured: Day 1 Period 4 following meal

  3. Correlation between drug concentrations & blood sugar levels:

    Measured: day 1 period 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2008 (estimated)
  2. Study start16 Nov 2007
  3. Primary completion10 Mar 2008
  4. Study completion10 Mar 2008

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00607906
Sponsor's protocol ID
AXO110461
Status last verified
Sep 2017
First submitted
23 Jan 2008
Last updated
6 Sep 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SB-756050 immediate release capsule and SB-756050 modified release capsule 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 18 inclusion and 59 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 6 Sep 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. 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?

adverse events: (time frame: each visit). The study lists 4 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 NCT00607906.

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 6 Sep 2017.

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