Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Male or female and age is between 18 and 55 years, inclusive;
All female subjects must have negative results for pregnancy tests performed;
If male, subject must be surgically sterile or practicing at least 1 of the following methods of contraception, from initial study drug administration through 90 days after administration of the last dose of study drug;
If male, subject agrees to abstain from sperm donation through 90 days after administration of the last dose of study drug;
Body Mass Index (BMI) is ≥ 18 to ≤ 31 kg/m2, inclusive;
A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG), as judged by the investigator.
You may not be if
Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the investigator;
Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
Requirement for any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis;
Recent (6-month) history of drug or alcohol abuse;
Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 30 days prior to study drug administration;
Positive screen results for drugs of abuse, alcohol, or cotinine at screening or Day -1;
Consumption of alcohol within 72 hours prior to study drug administration;
Consumption of grapefruit, grapefruit products, star fruit, star fruit products, or Seville oranges within the 72-hour period prior to study drug administration;
Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration;
17.10. Current enrollment in another clinical study.
Clareo Health | A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers
