Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763
NCT ID: NCT01619332
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
220 participants
INTERVENTIONAL
2012-03-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LEZ763
Part I- Healthy volunteers enrolled into 6 single-ascending dose cohorts Part II- Healthy volunteers enrolled into 5 multiple-ascending dose cohorts. Part III- LEZ763 will be given orally once daily for 28 days in a randomized and blinded manner
LEZ763
LEZ763 will be given orally once daily for 28 days in a randomized and blinded manner
Placebo
Part I : Healthy volunteers enrolled in 6 single ascending dose cohorts to receive matching placebo of LEZ763. Part II: Healthy volunteers enrolled in 5 multiple ascending dose cohorts to receive matching placebo of LEZ763. Part III- Placebo will be given orally once daily for 28 days to patients assigned to placebo in a randomized and blinded manner
Placebo
Placebo will be given orally once daily for 28 days to patients assigned to placebo in a randomized and blinded manner
Sitagliptin
Sitaglitpin will be given orally once daily for 28 days to patients assigned to this treatment in a randomized and blinded manner
Sitagliptin
Sitaglitpin will be given orally once daily for 28 days to patients assigned to this treatment in a randomized and blinded manner
Interventions
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Placebo
Placebo will be given orally once daily for 28 days to patients assigned to placebo in a randomized and blinded manner
Sitagliptin
Sitaglitpin will be given orally once daily for 28 days to patients assigned to this treatment in a randomized and blinded manner
LEZ763
LEZ763 will be given orally once daily for 28 days in a randomized and blinded manner
Eligibility Criteria
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Inclusion Criteria
* Male or female aged 18-65 yr,
* Subjects must weigh at least 50 kg to participate in the study. Body mass index (BMI) must be within the range of 18-37 kg/m2 (inclusive
* Only postmenopausal females or female subjects who report surgical sterilization (women without child bearing potential) will be allowed in this study.
* Subjects with stable conventional sleep-wake cycle
Normal Healthy Volunteers
* Healthy male or female subjects,
* must be in good health (as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at Screening).
Type II Diabetic Patients
* Type 2 diabetes diagnosed by American Diabetes Association criteria for at least 3 months prior to screening.
* Patients either drug naïve or on stable dose of metformin (stable dose for at least 4 weeks prior to Screening). The metformin dose should remain constant during the course of the study.
* HbA1c 6.5 to 9.5 % inclusive at screening
Exclusion Criteria
* Smokers (use of tobacco products in the previous 3 months).
* Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
* Significant illness within two weeks prior to dosing.
* Have (or have history of) drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations
Normal Healthy Volunteers
• History of diabetes, or adrenal disorders.
Type II Diabetic Patients
* Type 1 diabetes mellitus; positive anti-GAD antibodies; acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
18 Years
65 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Chula Vista, California, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Novartis Investigative Site
San Antonio, Texas, United States
Countries
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Related Links
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Results for CLEZ763X2201 from the Novartis Clinical Trials website
Other Identifiers
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CLEZ763X2201
Identifier Type: -
Identifier Source: org_study_id