Type 2 Diabetes
Conditions
Brief summary
This is a Phase 1 study, involving a 1-day dosing period, designed to test the safety of investigational study drug ARRY-403 in patients with Type 2 diabetes. Approximately 36 patients from the US will be enrolled in this study.
Interventions
single dose, escalating
DRUGPlacebo; oral
matching placebo
Sponsors
Array BioPharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female with willingness and ability to use protocol-specified methods of contraception, except females of nonchildbearing potential. * Diagnosis of Type 2 diabetes less than 5 years prior to study start. * HbA1c ≥ 6.5% and ≤ 10%. * BMI ≥ 25 and ≤ 40.0 kg/m2. * Additional criteria exist. Key
Exclusion criteria
* Recent history (i.e., less than 6 months) or concomitant/ongoing clinically significant hematologic, renal, pulmonary, gastrointestinal, hepatic, psychiatric, neurologic, dermatologic, or allergic disease (including drug allergies that are clinically significant and not remote, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * Significant cardiac disease, myocardial infarction within 6 months of study start, unstable angina, congestive heart failure, known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia. * History of gastric surgery, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption. * Active infectious diseases including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Past history and inactive hepatitis B and C, as confirmed by serological testing, are allowed. * A positive test for drugs or alcohol. * Women who are pregnant or breastfeeding. * Donation or loss of ≥ 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to first dose of study drug. * Additional criteria exist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. | Duration of study |
| Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations. | Day 1, Day 2 |
Secondary
| Measure | Time frame |
|---|---|
| Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers. | Day 1, Day 2 |
| Assess the ability of the study drug to improve glucose tolerance as determined by blood glucose monitoring during a standardized meal challenge. | Day 1, Day 2 |
| Assess the excretion of the study drug and metabolites in urine following dosing. | Day 1, Day 2 |
Countries
United States
Outcome results
None listed