First-Time-in-Humans Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of SB756050
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
1 other identifier
interventional
36
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes-mellitus-type-2
Started Nov 2007
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
November 16, 2007
CompletedFirst Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
February 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2008
CompletedSeptember 6, 2017
September 1, 2017
4 months
January 23, 2008
September 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
adverse events:
each visit
clinical laboratory:
day -1, day 2 each period
electrocardiogram (ECG):
day 1 each period
vital signs assessments:
day -1, day 1 each period
Secondary Outcomes (3)
plasma drug concentrations:
Day 1 each dosing level
plasma blood sugar & other parameter concentrations:
Day 1 Period 4 following meal
Correlation between drug concentrations & blood sugar levels:
day 1 period 4
Study Arms (5)
Subjects receiving treatment in cohort A1
EXPERIMENTALEligible subjects will receive oral immediate release capsules of SB-756050 with doses of 5 milligrams, 15 milligrams, 50 milligrams, or 100 milligrams.
Subjects receiving treatment in cohort A2
EXPERIMENTALEligible subjects will receive oral immediate release capsules of SB-756050 with doses of 100 milligrams, 200 milligrams, 300 milligrams, or 400 milligrams.
Subjects receiving treatment in cohort A3
EXPERIMENTALEligible 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.
Subjects receiving treatment in cohort A4
EXPERIMENTALEligible subjects will receive SB-756050 in this additional cohort.
Subjects receiving treatment in cohort B1
EXPERIMENTALEligible 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.
Interventions
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 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.
Subjects will also receive placebo capsules.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- 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
- +3 more criteria
You may not qualify if:
- 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.
- 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
- +43 more criteria
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
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2008
First Posted
February 6, 2008
Study Start
November 16, 2007
Primary Completion
March 10, 2008
Study Completion
March 10, 2008
Last Updated
September 6, 2017
Record last verified: 2017-09
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.