Levoketoconazole Food Effect Study in Healthy Subjects

NCT03768388 | Completed Phase 1 FDA Drug

• 1 other identifier: COR-2017-02
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Incidence of Adverse Events

  14 days

Study Arms (2)

Fasting State

OTHER

A single 600 mg dose of levoketoconazole administered in a fasting state.

Drug: levoketoconazole

Fed State

OTHER

A single 600 mg dose of levoketoconazole administered in a fed state.

Drug: levoketoconazole

Interventions

levoketoconazole DRUG

food effect

Also known as: COR-003

Fasting State; Fed State

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is 18-55 years of age, inclusive, at time of consent.
• Subject has a body mass index (BMI) between 18 and 32 kg/m2, inclusive.
• 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.
• 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.
• Subject has not consumed alcohol-containing beverages for 3 days prior to CRU admission and agrees not to consume alcohol through Follow-Up.
• 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.

You may not qualify if:

• 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.
• Concurrent medical illness that would interfere with the conduct of the study in the opinion of the Investigator.
• 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.
• 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.
• 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.
• Subject is positive for Human Immunodeficiency Virus (HIV), hepatitis B, and/or hepatitis C on Screening assessments.
• Subject has an acute illness within 7 days of CRU admission.
• Subject has donated plasma within 7 days of drug administration.
• Subject has donated 1 or more pints of blood (or equivalent blood loss) within 30 days prior to drug administration.
• 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.
• Female subjects who are pregnant or lactating.
• Males with hemoglobin less than 12.0 g/dL; Females with hemoglobin less than 11.0 g/dL.
• Subjects who have had difficulties with swallowing whole tablets.
• Subjects with body habitus preventing repeated venipuncture as required by protocol.

Sponsors & Collaborators

• Cortendo AB: lead

Study Sites (1)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

Study Officials

• Steven Schoenfeld, MD

  Cortendo AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 7, 2018
• Study Start: November 30, 2018
• Primary Completion: December 24, 2018
• Study Completion: December 24, 2018
• Last Updated: February 4, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)