Levoketoconazole Food Effect Study in Healthy Subjects
Study Details
Study Description
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 |
|---|---|---|
| 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Fasting State A single 600 mg dose of levoketoconazole administered in a fasting state. |
Drug: levoketoconazole
food effect
Other Names:
|
| Other: Fed State A single 600 mg dose of levoketoconazole administered in a fed state. |
Drug: levoketoconazole
food effect
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum observed plasma concentration (Cmax) of levoketoconazole [24 hours]
Maximum observed plasma concentration (Cmax) of levoketoconazole for fed vs. fasted condition
- Time to maximum concentration (Tmax) of levoketoconazole [24 hours]
Time to maximum concentration (Tmax) of levoketoconazole for fed vs. fasted condition
- Apparent Terminal Elimination Phase Rate Constant (λz) of levoketoconazole [24 hours]
Apparent Terminal Elimination Phase Rate Constant (λz) of levoketoconazole for fed vs. fasted condition
- Terminal phase half-life (t 1/2) of levoketoconazole [24 hours]
Terminal phase half-life (t 1/2) of levoketoconazole for fed vs. fasted condition
- Area under the plasma concentration-time curve (AUC) of levoketoconazole [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
- Incidence of Adverse Events [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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is 18-55 years of age, inclusive, at time of consent.
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Subject has a body mass index (BMI) between 18 and 32 kg/m2, inclusive.
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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.
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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.
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Subject has not consumed alcohol-containing beverages for 3 days prior to CRU admission and agrees not to consume alcohol through Follow-Up.
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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:
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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.
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Concurrent medical illness that would interfere with the conduct of the study in the opinion of the Investigator.
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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.
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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.
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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.
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Subject is positive for Human Immunodeficiency Virus (HIV), hepatitis B, and/or hepatitis C on Screening assessments.
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Subject has an acute illness within 7 days of CRU admission.
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Subject has donated plasma within 7 days of drug administration.
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Subject has donated 1 or more pints of blood (or equivalent blood loss) within 30 days prior to drug administration.
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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.
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Female subjects who are pregnant or lactating.
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Males with hemoglobin less than 12.0 g/dL; Females with hemoglobin less than 11.0 g/dL.
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Subjects who have had difficulties with swallowing whole tablets.
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Subjects with body habitus preventing repeated venipuncture as required by protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Pharmacology of Miami, LLC | Miami | Florida | United States | 33014 |
Sponsors and Collaborators
- Cortendo AB
Investigators
- Study Director: Steven Schoenfeld, MD, Cortendo AB
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COR-2017-02