Bioavailability and Food Effect Study of 3 Types of Carisbamate (NCT04520360) | Clinical Trial Compass
CompletedPhase 1
Bioavailability and Food Effect Study of 3 Types of Carisbamate
United States33 participantsStarted 2020-08-27
Plain-language summary
This study is designed to examine the relative bioavailability of three carisbamate formulations (Oral Suspension Type 1, Oral Suspension Type 2, and a 300 mg Oral Tablet) and to assess the effect of food on the oral bioavailability of the Oral Suspension Type 2 and the 300 mg Oral Tablet.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Male or female subjects of 18 to 50 years of age (inclusive)
✓. Able to read, understand, sign, and date a written informed consent form (ICF) before study participation at screening
✓. Agree to use 2 highly effective methods of contraception, including at least one barrier method
✓. Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening
✓. Judged to be in good health based on medical history, physical examination, and routine laboratory measurements (i.e., without clinically relevant pathology)
✓. Normal electrocardiogram (ECG) (12-lead), arterial blood pressure, and heart rate within the normal standard range used by the study center or considered not clinically significant by the Investigator and in agreement with the Sponsor
✓. Able to understand and comply with protocol requirements and instructions and likely to complete the study as planned
✓. A female study subject of childbearing potential must agree to use one of the accepted contraceptive method from Screening, during the study, and for at least 90 days after the last dose of the study medication. Hormonal contraceptives alone will not be considered an adequate method of contraception.
Exclusion criteria
✕. Smokers (subjects who have smoked within 6 months prior to screening or those subjects with a positive result from the smoking screening assay)
✕. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the study drug (except appendectomy and simple hernia repair).
✕. Regular treatment with prescription medications. Subjects should have ended any prescription medications at least 14 days before the first dosing of the study drug. Potential subjects should only stop any prescribed medication at the direction of a physician or qualified medical professional.
✕. Regular treatment with nonprescription medications. Subjects should have ended any nonprescription medications at least 14 days before the first dosing of the study drug. Potential subjects should consult with a physician or qualified medical professional before stopping any regular treatment with nonprescription medication.
✕. Consumption of herbal medications, dietary supplements, and specific fruit products. Subjects should have stopped consumption of herbal medications or dietary supplements (e.g., St. John's Wort, ginkgo biloba, and garlic supplements), vitamins, and grapefruit or grapefruit juice, or Seville oranges at least 14 days before the first dosing of study drug.
✕. History of drug or alcohol abuse or addiction within 2 years before the start of study drug dosing, or a positive test results for alcohol or drugs of abuse, such as amphetamine, barbiturate, benzodiazepine, cocaine, methadone, opiates, oxycodone, phencyclidine, propoxyphene, cannabinoid (THC), MDMA (Ecstasy), methaqualone, and tricyclic antidepressant (TCA).
✕. Regular consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 pint \[473 mL\] of beer or lager, 1 glass \[125 mL\] of wine, 25 mL shot of 40% spirit) before screening. Subjects may not consume any alcohol from 72 hours before the first dosing of study drug through the completion of the last PK sampling.
✕. Consumption of an average of more than 5 servings per day of coffee, tea, chocolate, cola, or other caffeinated or methyl xanthine beverages before screening. Subjects may not consume any tea, coffee, chocolate, and other foods and beverages containing caffeine and other methyl xanthine derivatives from 48 hours prior to dosing until the collection of the last PK sample.