Status and phase
Conditions
Treatments
About
The primary objectives of the study are to:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subject or legally authorized representative signs an Institutional Review Board (IRB)-approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act [HIPAA] authorization for sites in the United States) before any study-related procedures (including withdrawal of prohibited medication, if applicable) are performed
Age 18 to 50 years
Body mass index (BMI) 18-32 kg/m2
Clinical and laboratory findings consistent with good health in the opinion of the investigator
Women of non-childbearing potential or men who agree to utilize adequate contraception throughout the study
Women of non-childbearing potential must be one of the following:
Male subjects who are not surgically sterile must agree to use one of the following birth control methods if sexually active:
Exclusion criteria
Positive results on any of the following tests at Screening or Day -1:
urine pregnancy (women only), urine drugs of abuse and alcohol, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody
Concurrent clinically significant medical diagnosis that would potentially interfere with the subject's study compliance or confound the study results
Concurrent social conditions (e.g., drug or alcohol abuse, transportation difficulties) that would potentially interfere with the subject's study compliance
Clinically significant illness within 30 days preceding entry into the study
Participation in an investigational drug study within 30 days or 5 half-lives, whichever is longer, before Screening
Use of prescription medications within 14 days before Day 1 and throughout the study. (The use of non-prescription or over-the-counter medications is prohibited within 7 days before Day 1 and throughout the study. This includes all herbal supplements or remedies and vitamins.)
Primary purpose
Allocation
Interventional model
Masking
24 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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