Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Zealand Pharma
Age
18–60
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
Body Mass index between 18 and 30.0 kg/m2
Able to comply with all the trial procedures
females will not be pregnant or lactating
If female of childbearing potential or male agree to use contraception as defined in the protocol
Male subjects must also be willing to refrain from donating sperm from trial Check-in until 90 days after the last dose
You may not be if
Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
History of bowel obstruction, stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and/or cholecystectomy or hernia repair will be allowed).
Clinically significant abnormality on 12-lead ECG
Clinically significant abnormality in hematology, clinical chemistry, or urinalysis
History of alcoholism or drug/chemical abuse within 2 years
Alcohol consumption of \> 21 units per week for males and \> 14 units for females
Positive urine drug screen
Positive hepatitis panel and/or positive human immunodeficiency test
Receipt of any investigational product within 30 days or 5 half-lives
Previous exposure to GLP-1, GLP-2, human growth hormone, or analogs thereof 30 days prior to Check-in
Use or intend to use any medications/products known to be strong inhibitors or strong inducers of cytochrome P450 3A enzyme, including St. John's wort
Use of tobacco, smoking cessation products, or products containing nicotine (including but not limited to cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine lozenges, or nicotine gum ) within 3 months prior to Screening
Receipt of blood products within 2 months prior to Check-in and throughout the trial.
Donation of blood or significant blood loss from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening and throughout the trial.
