Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a three part study to assess the safety and efficacy of LEZ763 on normal healthy volunteers and patients with Type 2 Diabetes.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion criteria:

• All subjects: (suggest this will reduce duplication)

• 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:

All subjects:

• 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

• Evidence of clinically significant diabetic complications (such nephropathy, retinopathy, neuropathy) Other protocol defined inclusion/exclusion criteria may apply