Drug Interaction Study of Levoketoconazole and Metformin

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the effect of levoketoconazole on the single-dose PK of metformin in health subjects.

Key facts

Study ID

NCT03880825

Run by

Cortendo AB

People needed

32

Starts

2019-03-28

Expected to finish

2019-05-03

Last updated by the study team

2019-08-30

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18-55 years of age, inclusive, at time of consent.
• Body mass index (BMI) between 18 and 32 kg/m2, inclusive.
• 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.
• 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 initial CRU admission on Day -1 and through Follow-Up.
• Has not consumed alcohol-containing beverages for 3 days prior to initial CRU admission on Day -1 and agrees not to consume alcohol for the duration of the study through Follow-Up.
• 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 (except for LFTs, which must be within the normal range).
• 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.
• Clinically significant ECG abnormality or confirmed QTcF interval > 450 msec at Screening or unconfirmed QTcF interval > 450 msec at CRU admission.
• Family history (parents, siblings, and offspring) of QT interval sudden cardiac death.
• Positive urine drug screen for drugs-of-abuse, including cocaine, 3,4 methylenedioxy-methamphetamine (MDMA), tetrahydrocannabinol, opioids, benzodiazepines, amphetamines, and barbiturates, and/or positive urine screen for alcohol at Screening and CRU admission.
• Positive urinary cotinine test at Screening.
• 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.
• Positive for Human Immunodeficiency Virus (HIV), hepatitis B, and/or hepatitis C on Screening assessments.
• Acute illness within 7 days of the first CRU admission on Day -1.
• Donated plasma within 7 days of Screening.
• Donated 1 or more pints of blood (or equivalent blood loss) within 30 days prior to Screening.
• 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.
• History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of hard liquor) within 180 days of Screening.
• Female subject who is pregnant or lactating.
• Male with hemoglobin less than 12.0 g/dL; Female with hemoglobin less than 11.0 g/dL.
• Had difficulties swallowing whole tablets.
• Body habitus prevents repeated venipuncture.
• History of hypersensitivity or allergy to metformin.
• History of hypoglycemia.
• Participated in the COR-2017-02 levoketoconazole food effect study.
• History of drug-induced liver injury from any drug.

Where it is running

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

Full record on ClinicalTrials.gov

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