A Phase 1 interventional study of BMS-767778 or Placebo in Type 2 Diabetes Mellitus, sponsored by Bristol-Myers Squibb. Terminated at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-02-10.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
To assess the safety and tolerability and the PK/PD relationship of BMS-767778 administered as single and multiple oral doses in healthy subjects, and in subjects with T2DM
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Parts A and Part B of the study (maximum age 45 years):
Inclusion Criteria:
Exclusion Criteria:
Part C of the study (maximum age 65 years):
Inclusion criteria:
Exclusion criteria:
A: BMS-767778, Oral Solution, Oral, 1 mg, once daily, 1 day OR Placebo Comparator, Oral Solution, Oral, 0 mg, once daily, 1 day B: BMS-767778, Oral Solution, Oral, 3 mg, once daily, 1 day OR Placebo Comparator, Oral Solution, Oral, 0 mg, once daily, 1 day C: BMS-767778, Capsules, Oral, 10 mg, once daily, 1 day OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 1 day D: BMS-767778, Capsules, Oral, 30 mg, once daily, 1 day OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 1 day E: BMS-767778, Capsules, Oral, 100 mg, once daily, 1 day OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 1 day F: BMS-767778, Capsules, Oral, 300 mg, once daily, 2 days OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 2 days G: BMS-767778, Capsules, Oral, 600 mg, once daily, 1 day OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 1 day
Drug: BMS-767778 or Placebo
A: BMS-767778, Capsules, Oral, 10 mg, once daily, 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 14 days B: BMS-767778, Capsules, Oral, 30 mg, once daily, 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 14 days C: BMS-767778, Capsules, Oral, 100 mg, once daily, 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 14 days D: BMS-767778, Capsules, Oral, 300 mg, once daily, 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 14 days E: BMS-767778, Capsules, Oral, 600 mg, once daily, 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 14 days
Drug: BMS-767778 or Placebo
A: BMS-767778, Capsules, Oral, Adaptive design (between 10 to 600 mg), 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, 14 days B: BMS-767778, Capsules, Oral, Adaptive design (between 10 to 600 mg), 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, 14 days
Drug: BMS-767778 or Placebo
AEs, vital signs, ECG and clinical laboratory test results
Time frame: throughout the study
Single and multiple dose (14 days) PK
Time frame: throughout the study
DPP-4 inhibition and incretin response
Time frame: throughout the study
This study is terminated, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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