Bioavailability of Levoketoconazole and Ketoconazole Tablets

NCT ID: NCT04212000

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-16
• Study Completion Date: 2020-01-23

Brief 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).

Detailed Description

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). Subjects will be randomized to receive a single oral dose of 150 mg levoketoconazole (Study Drug A) or a single oral dose of 200 mg ketoconazole (Study Drug B) in each period.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Levoketoconazole

Levoketoconazole 150 mg

Group Type: EXPERIMENTAL

Levoketoconazole

Intervention Type: DRUG

Levoketoconazole tablet

Ketoconazole

Ketoconazole 200 mg

Group Type: ACTIVE_COMPARATOR

Ketoconazole

Intervention Type: DRUG

Ketoconazole tablet

Interventions

Levoketoconazole

Levoketoconazole tablet

Intervention Type: DRUG

Ketoconazole

Ketoconazole tablet

Intervention Type: DRUG

Other Intervention Names

COR-003

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cortendo AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier Valencia, MD

Role: STUDY_DIRECTOR

Cortendo AB

Locations

Pharmaceutical Research Associates, Inc.

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

LKC101A

Identifier Type: -

Identifier Source: org_study_id