Overview

Bioavailability of Levoketoconazole and Ketoconazole Tablets

Status:
Completed
Trial end date:
2020-01-23
Target enrollment:
0
Participant gender:
All
Summary
This is a phase 1, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the relative oral bioavailability of levoketoconazole tablets (the test drug) and ketoconazole tablets (the reference drug product).
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Cortendo AB
Treatments:
Ketoconazole
Criteria
Inclusion Criteria:

1. 18 to 55 years of age, inclusive, at time of consent.

2. Body mass index (BMI) between 18.0 and 32.0 kg/m2,inclusive.

3. In good general physical health as determined by absence of clinically significant
medical history, physical examination findings, vital signs, clinical laboratory
evaluations, and ECG measurements.

4. Has not consumed and agrees to abstain from taking any prescription drugs, dietary
supplements including vitamins and herbal preparations, or non-prescription drugs for
14 days prior to clinical research unit (CRU) admission, during washout period, and
through Follow-Up.

5. Has not consumed alcohol-containing beverages for 3 days prior to CRU admission and
agrees not to consume alcohol through Follow-Up.

6. Is a nonsmoker (for at least 3 months) with negative urinary cotinine test at
Screening and agrees to abstain from tobacco-and nicotine-containing products for the
duration of the study.

Exclusion Criteria:

1. Evidence of any out-of-normal-range laboratory value at Screening that has not been
reviewed, approved, and documented as Not Clinically Significant by the Investigator.

2. Concurrent medical illness that would interfere with the conduct of the study in the
opinion of the Investigator.

3. History or presence of clinically significant cardiovascular, pulmonary, hematologic,
endocrine, immunologic, dermatologic, neurologic, psychiatric, renal, hepatic, chronic
respiratory, or gastrointestinal disease as judged by the Investigator.

4. Positive urine drug screen for drugs-of-abuse, including cocaine,
tetrahydrocannabinol, opioids, benzodiazepines, amphetamines, and barbiturates,and/or
positive urine screen for alcohol at Screening and CRU admission.

5. Treatment with an investigational drug within the longer of 30 days or five half-lives
of the investigational drug preceding the first dose of study drug.

6. Positive for HIV, hepatitis B, and/or hepatitis C on Screening assessments.

7. Acute illness within 7 days of CRU admission.

8. Donated plasma within 7 days of drug administration.

9. Donated 1 or more pints of blood (or equivalent blood loss) within 30 days prior to
drug administration.

10. History of caffeine consumption exceeding 8 cups coffee/day within 14 days prior to
first dose, or consumption of any caffeine-or chocolate-containing products for 3 days
prior to CRU admission each week.

11. Female subjects who are pregnant or lactating.

12. Males with hemoglobin less than 12.0 g/dL at Screening or CRU admission; Females with
hemoglobin less than 11.0 g/dL at Screening or CRU admission

13. Had difficulties with swallowing whole tablets.

14. Body habitus preventing repeated venipuncture as required by protocol.