Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cardurion Pharmaceuticals, Inc.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
1. Males or females, of any race, between 18 and 55 years of age, inclusive.
2. Body mass index between 18.0 and 32.0 kg/m2, inclusive.
3. In good health, determined by no clinically significant findings as assessed by the investigator.
4. Adhere to all contraception criteria.
You may not be if
1. Significant medical history as determined by the investigator.
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, including itraconazole, unless approved by the investigator (or designee).
3. History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
4. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator.
5. History or presence of an abnormal ECG.
6. Use or intend to use any medications/products/herbal remedies known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to check-in, unless deemed acceptable by the investigator (or designee).
7. Drugs affecting CYP3A4 should be refrained from use for 3 weeks, or 5 half-lives (whichever is longer), prior to check-in through to follow-up.
8. Positive urine drug screen at screening or positive alcohol breath test result or positive urine drug screen at check-in.21. History of alcoholism or drug/chemical abuse within 12 months prior to check-in.
9. Ingestion of poppy seed, Seville orange, or grapefruit containing foods or beverages within 7 days prior to check-in.
