Levoketoconazole Food Effect Study in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Fasting State; A single 600 mg dose of levoketoconazole administered in a fasting state.	Drug: levoketoconazole; food effect; Other Names: COR-003
Other: Fed State; A single 600 mg dose of levoketoconazole administered in a fed state.	Drug: levoketoconazole; food effect; Other Names: COR-003

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax) of levoketoconazole	Maximum observed plasma concentration (Cmax) of levoketoconazole for fed vs. fasted condition	24 hours
Time to maximum concentration (Tmax) of levoketoconazole	Time to maximum concentration (Tmax) of levoketoconazole for fed vs. fasted condition	24 hours
Apparent Terminal Elimination Phase Rate Constant (λz) of levoketoconazole	Apparent Terminal Elimination Phase Rate Constant (λz) of levoketoconazole for fed vs. fasted condition	24 hours
Terminal phase half-life (t 1/2) of levoketoconazole	Terminal phase half-life (t 1/2) of levoketoconazole for fed vs. fasted condition	24 hours
Area under the plasma concentration-time curve (AUC) of levoketoconazole	Area under the plasma concentration-time curve (AUC) from time 0 to time of last measurable plasma concentration (AUClast) and from time 0 extrapolated to infinity (AUCinf) of levoketoconazole for fed vs. fasted condition	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	AEs leading to discontinuation, AEs of Special Interest (AESIs), AEs related to study drug and AE severity will be summarized by study treatment	14 days

Collaborators and Investigators

• Sponsor: Cortendo AB

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Actual): December 24, 2018
• Study Completion (Actual): December 24, 2018

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: COR-2017-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No