First-Time-in-Humans Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of SB756050
This study has been completed.
Information provided by:
First received: January 23, 2008
Last updated: October 14, 2010
Last verified: October 2010
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.
Type 2 Diabetes Mellitus
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- adverse events: [ Time Frame: each visit ]
- clinical laboratory: [ Time Frame: day -1, day 2 each period ]
- electrocardiogram (ECG): [ Time Frame: day 1 each period ]
- vital signs assessments: [ Time Frame: day -1, day 1 each period ]
Secondary Outcome Measures:
- plasma drug concentrations: [ Time Frame: Day 1 each dosing level ]
- plasma blood sugar & other parameter concentrations: [ Time Frame: Day 1 Period 4 following meal ]
- Correlation between drug concentrations & blood sugar levels: [ Time Frame: day 1 period 4 ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2008 (Final data collection date for primary outcome measure)
Other Name: SB756050
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607906
|GSK Investigational Site
|Minneapolis, Minnesota, United States, 55404 |
||GSK Clinical Trials, MD
No publications provided
||Study Director, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 23, 2008
||October 14, 2010
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases