Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740
Study Details
Study Description
Brief Summary
This is a Phase 1, single-site, open-label, fixed sequence crossover study to investigate the effect of coadministration of itraconazole on the pharmacokinetics of CRD-740 in healthy male and female subjects. Subjects will be admitted into the study site on Day -1 and will be confined to the study site until discharge on Day 16. Subjects will receive CRD-740 orally on Days 1 and 10. Itraconazole will be given once daily, orally, on Days 7 through 15.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: CRD-740 CRD-740 single dose administered alone |
Drug: CRD-740
CRD-740
|
| Other: CRD-740 and Itraconazole CRD-740 single dose administered with Itraconazole |
Drug: CRD-740
CRD-740
Drug: Itraconazole
Itraconazole
|
Outcome Measures
Primary Outcome Measures
- AUC0-24 of CRD-740 alone and with coadministration of itraconazole [Day 1 to Day 16]
- AUC0-inf of CRD-740 alone and with coadministration of itraconazole [Day 1 to Day 16]
- AUC0-t of CRD-740 alone and with coadministration of itraconazole [Day 1 to Day 16]
- Cmax of CRD-740 alone and with coadministration of itraconazole [Day 1 to Day 16]
Secondary Outcome Measures
- Half life (t1/2) of CRD-740 [Day 1 to Day 16]
- Time to maximum concentration (Tmax) of CRD-740 [Day 1 to Day 16]
- Oral clearance (CL/F) of CRD-740 [Day 1 to Day 16]
- Apparent volume of distribution during terminal phase (Vz/F) of CRD-740 [Day 1 to Day 16]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males or females, of any race, between 18 and 55 years of age, inclusive.
-
Body mass index between 18.0 and 32.0 kg/m2, inclusive.
-
In good health, determined by no clinically significant findings as assessed by the investigator.
-
Adhere to all contraception criteria.
Exclusion Criteria:
-
Significant medical history as determined by the investigator.
-
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, including itraconazole, unless approved by the investigator (or designee).
-
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).
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Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator.
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History or presence of an abnormal ECG.
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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).
-
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.
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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.
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Ingestion of poppy seed, Seville orange, or grapefruit containing foods or beverages within 7 days prior to check-in.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardurion Investigative Site | Dallas | Texas | United States | 75247 |
Sponsors and Collaborators
- Cardurion Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRD-740-101