Clinical trial NCT03768388: Levoketoconazole Food Effect Study in Healthy Subjects
Official title: A Phase I Randomized, Open-Label, Two-Period, Two-Sequence Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Levoketoconazole in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Cortendo AB
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a phase I, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the effect of food on the PK of levoketoconazole.

Detailed description: In each period of the randomized, two period crossover study, levoketoconazole will be administered orally as a single dose of 600 mg levoketoconazole to subjects in the fasted state or fed (at 30 minutes after beginning consumption of a standardized high-fat meal). Subjects assigned to one treatment in Period 1 will be assigned to the opposite treatment in Period 2.

Eligibility criteria: Inclusion Criteria:

1. Subject is 18-55 years of age, inclusive, at time of consent.
2. Subject has a body mass index (BMI) between 18 and 32 kg/m2, inclusive.
3. Subject is 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. Subject has not consumed and agrees to abstain from taking any prescription drugs, dietary supplements including vitamins and herbal preparations, or non-prescription drugs (except as authorized by the Investigator AND Medical Monitor) for 14 days prior to CRU admission, during washout period, and through Follow-Up.
5. Subject has not consumed alcohol-containing beverages for 3 days prior to CRU admission and agrees not to consume alcohol through Follow-Up.
6. Subject 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. Subject is positive for Human Immunodeficiency Virus (HIV), hepatitis B, and/or hepatitis C on Screening assessments.
7. Subject has an acute illness within 7 days of CRU admission.
8. Subject has donated plasma within 7 days of drug administration.
9. Subject has 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 of coffee/day (1 cup = 8 fluid ounces) 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. Caffeine-containing foods and/or beverages (e.g., tea and cola) should be considered equivalent to coffee.
11. Female subjects who are pregnant or lactating.
12. Males with hemoglobin less than 12.0 g/dL; Females with hemoglobin less than 11.0 g/dL.
13. Subjects who have had difficulties with swallowing whole tablets.
14. Subjects with body habitus preventing repeated venipuncture as required by protocol.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of levoketoconazole
timeFrame: 24 hours
measure: Time to maximum concentration (Tmax) of levoketoconazole
timeFrame: 24 hours
measure: Apparent Terminal Elimination Phase Rate Constant (λz) of levoketoconazole
timeFrame: 24 hours
measure: Terminal phase half-life (t 1/2) of levoketoconazole
timeFrame: 24 hours
measure: Area under the plasma concentration-time curve (AUC) of levoketoconazole
timeFrame: 24 hours
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: 14 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
Study officials:
affiliation: Cortendo AB
name: Steven Schoenfeld, MD
role: STUDY_DIRECTOR
References: