A Trial to Evaluate the Impact of C21 on the Exposure of 4 Substrates in Healthy Volunteers

Exclusion Criteria

• •1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the trial, or influence the results or the subject's ability to participate in the trial.
• •2. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
• •3. Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
• •4. Any planned major surgery within the duration of the trial.
• •5. Subjects who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
• •6. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or human immunodeficiency virus (HIV).
• •7. After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges:
• •* Systolic blood pressure: \<90 or \>140 mmHg, or
• •* Diastolic blood pressure \<50 or \>90 mmHg, or
• •* Pulse \<40 or \>90 bpm
• •8. Prolonged QTcF (\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the screening visit, as judged by the Investigator.
• •9. CYP2C9 genotype hetero- or homozygous for CYP2C9\*2 (Arg144Cys) and/or CYP2C9\*3 (Ile359Leu) variant alleles associated with altered CYP2C9 activity and tolbutamide metabolism \[14\], sampled at the screening visit.
• •10. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to any of the IMPs.
• •11. Regular use of any prescribed or non-prescribed medications, including antacids, analgesics, herbal remedies, e.g. St. John's wort, vitamins and minerals, within 2 weeks prior to the first administration of IMP, except occasional intake of paracetamol (maximum 2000 mg/day and not exceeding 3000 mg/week), as well as nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days, at the discretion of the Investigator.
• •12. Planned treatment or treatment with another investigational drug within 3 months prior to Day -1. Subjects consented and screened but not dosed in previous phase 1 studies are not to be excluded.
• •13. Regular current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than 3 times/week is allowed before the screening visit.
• •14. Positive screening result for drugs of abuse or alcohol at the screening visit or on admission to the trial site prior to the first administration of the IMP.
• •15. History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
• •16. Presence or history of drug abuse, as judged by the Investigator.
• •17. History of, or current use of anabolic steroids, as judged by the Investigator.
• •18. Excessive caffeine consumption defined by a daily intake of \> 5 cups (1 cup = approximately 240 mL) of caffeine containing beverages, as judged by the Investigator.
• •19. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the last three months prior to screening.
• •20. The Investigator considers the subject unlikely to comply with trial procedures, restrictions and requirements.