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A Study to Determine the Safety, Tolerability, and Effects of GSK2374697 in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Determine the Safety, Tolerability, and Effects of GSK2374697 in Healthy Volunteers

A Single-blinded, Randomized, Placebo-controlled, Staggered-parallel, Escalating Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2374697 in Healthy Volunteers

NCT01545570•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This is a single-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK2374697 in healthy volunteers. The study will enrol approximately 72 subjects at one clinical study center in the United States.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and Holter monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included if the investigator and the GSK Medical Monitor (or designee) agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or objectives. Subjects with values outside the ranges noted below should be excluded from enrollment, unless the investigator and GSK medical monitor (or designee) agree that the value in question would not pose a significant safety risk for the subject or compromise the study objectives. Please see Section 7.1 for additional information.
•Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
•A female subject is eligible to participate if she is of:
•Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<147 pmol/L) is confirmatory\]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2- 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study.
•Body weight ≥ 50.0 kg and BMI within the range 19.9 - 35 kg/m2 (inclusive).
•Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
•Single or Average QTcB \< 450 msec.
•AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN at screening and at baseline (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).

Exclusion Criteria

•A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
•A positive test for HIV antibody.
•History of chronic or acute pancreatitis. Note: Subjects with a lipase value above the upper limit of normal (ULN) at screening are excluded. If amylase result is above ULN and lipase is below ULN, an amylase isoenzyme analysis may be performed. If this additional test confirms that the pancreatic amylase isoenzyme fraction is not the cause of the elevation, the subject may enroll in the study.
•History of thyroid disease: personal or family history of thyroid cancer unless approved by the GSK medical monitor (or designee), and/or a history of uncorrected thyroid dysfunction or an abnormal thyroid function as assessed by TSH, and/or plasma calcitonin at screening \> 50pg/mL.
•History of- or family history of a renal disorder that may compromise renal function
•Creatinine clearance \< 80 mL/min. (estimated from serum creatinine (SCr) and demographic data using the Cockcroft-Gault calculation):
•To calculate estimated Cockcroft-Gault GFR (mL/min) manually:
•= (140 - age) \* (weight in kg) \* (0.85 if female) / (72 \* Cr in mg/dL)
•History of regular alcohol consumption within 6 months of the study defined as:
•An average weekly intake of \>14 drinks for males or \>7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
+3 more criteria

Locations (1)

GSK Investigational Site

Minneapolis, Minnesota, United States

Key Dates

Start Date

November 7, 2011

Primary Completion Date

December 23, 2012

Completion Date

December 23, 2012

Last Updated

July 25, 2017

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

GSK2376497

DRUG

0.9% sodium chloride

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Determine the Safety, Tolerability, and Effects of GSK2374697 in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

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