Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

The purpose of this study is to evaluate the safety profile, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) following single and multiple oral doses of BMS-963272 in healthy subjects.

Key facts

Study ID

NCT02327273

Run by

Bristol-Myers Squibb

People needed

88

Starts

2014-10-01

Expected to finish

2015-05-01

Last updated by the study team

2015-07-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
• Body Mass Index (BMI) of 27 to 40 kg/m2 inclusive. BMI = weight (kg)/ [height (m)]2
• Females (not of childbearing potential and males, ages 18 to 55 years, inclusive. Female subjects must have documented proof that they are not of childbearing potential
• Azoospermic males and women who are not of child-bearing potential (i.e. are postmenopausal or surgically sterile; see section 3.3.3 for the definition of WOCBP) are exempt from contraceptive requirements. However, women must still undergo pregnancy testing as described in this section

You may not qualify if…

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
• Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat.
• i)PR ≥ 210 msec ii)QRS ≥ 120 msec iii)QT ≥ 500 msec iv)QTcF ≥ 450 msec
• Positive urine screen for drugs of abuse
• Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
• Moderate anemia (hemoglobin < 11 g/dL for men and < 10 g/dL for women)
• aspartate aminotransferase (AST) > 1.3x ULN
• alanine aminotransferase (ALT) > 1.3x ULN
• Total bilirubin > 1.3x upper limit of normal (ULN)
• estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73 m2 (calculated using CKD-EPI formula)
• HbA1c > 6.5%
• Fasting total cholesterol > 300 mg/dl
• Fasting triglycerides > 400 mg/dl
• Systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 95 mm Hg, confirmed by repeat measurement
• History of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
• History of lactose intolerance

Where it is running

• Ppd Development, Lp — Austin, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.