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Levoketoconazole Food Effect Study in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03768388
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Cortendo AB

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: levoketoconazole Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : November 30, 2018
Actual Primary Completion Date : December 24, 2018
Actual Study Completion Date : December 24, 2018

Arm Intervention/treatment
Fasting State
A single 600 mg dose of levoketoconazole administered in a fasting state.
Drug: levoketoconazole
food effect
Other Name: COR-003

Fed State
A single 600 mg dose of levoketoconazole administered in a fed state.
Drug: levoketoconazole
food effect
Other Name: COR-003




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of levoketoconazole [ Time Frame: 24 hours ]
    Maximum observed plasma concentration (Cmax) of levoketoconazole for fed vs. fasted condition

  2. Time to maximum concentration (Tmax) of levoketoconazole [ Time Frame: 24 hours ]
    Time to maximum concentration (Tmax) of levoketoconazole for fed vs. fasted condition

  3. Apparent Terminal Elimination Phase Rate Constant (λz) of levoketoconazole [ Time Frame: 24 hours ]
    Apparent Terminal Elimination Phase Rate Constant (λz) of levoketoconazole for fed vs. fasted condition

  4. Terminal phase half-life (t 1/2) of levoketoconazole [ Time Frame: 24 hours ]
    Terminal phase half-life (t 1/2) of levoketoconazole for fed vs. fasted condition

  5. Area under the plasma concentration-time curve (AUC) of levoketoconazole [ Time Frame: 24 hours ]
    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


Secondary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: 14 days ]
    AEs leading to discontinuation, AEs of Special Interest (AESIs), AEs related to study drug and AE severity will be summarized by study treatment



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768388


Locations
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United States, Florida
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33014
Sponsors and Collaborators
Cortendo AB
Investigators
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Study Director: Steven Schoenfeld, MD Cortendo AB

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Responsible Party: Cortendo AB
ClinicalTrials.gov Identifier: NCT03768388     History of Changes
Other Study ID Numbers: COR-2017-02
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No