A PHASE 1, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTIPLE DOSE, PARALLEL ARM STUDY TO EVALUATE THE EFFECT OFMEAL TIMING AND FOOD- VERSUS THE FASTED STATE ON THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF REPETITIVE DAILY DOSES OF TONABERSAT (USL260) IN HEALTHY SUBJECTS
- Conditions
- Migraine10019231
- Registration Number
- NL-OMON35227
- Lead Sponsor
- psher-Smith Laboratories, Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
* Age 18 to 65 years, inclusive. ;* Male or non-pregnant and not breast feeding female (non-pregnancy will be confirmed by a serum pregnancy test conducted at Screening and prior to any dosing period).;Female subjects of childbearing potential must be:;o On oral contraceptive therapy; or,;o Practicing acceptable double-barrier methods of birth control during the course of the study (e.g., a barrier method using a condom with spermicide, diaphragm with spermicide, or cervical cap with spermicide); or ;o Surgically sterile (bilateral tubal ligation 90 days or more prior to dosing, bilateral oopherectomy, or hysterectomy).;Female subjects who are post- menopausal must be:;o Postmenopausal (no menses) for at least 1 year and have a documented follicle stimulating hormone (FSH) level *30 mIU/ml.;o Post-menopausal females may be on hormone replacement therapy.;* Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive, and weigh at least 50 Kg (110 lbs.).;* Physical examination is within normal limits; a subject with a clinical abnormality could be included only if the investigator considers that it would not introduce any additional risk to the subject nor interfere with study procedures.;* Grapefruit juice is not allowed 7 days prior to dosing, throughout the entire clinic period (through Day 21), and until after the completion of Day 28 PK blood samples are collected. ;* Theobromide-, alcohol-, caffeine-, and xanthine-containing beverages or food (coffee, tea, cola beverages, chocolate, *power drinks*) are not allowed for 48 hours (2 days) prior to dosing, throughout the entire clinic period, until the morning of Day 28.;* All hematology and clinical chemistry values for blood and urine are within the normal range or show no relevant deviations as judged by the medical investigator.;* Subject is a *light smoker*, i.e., he/she smokes no more than 5 cigarettes (1/4 pack) per day.;* Is able to communicate effectively with study personnel and are considered reliable, able, willing and cooperative with regard to complying with protocol-defined requirements as assessed by the study investigator.;* Can voluntarily give written informed consent to participate in the study prior to the completion of any study-related procedures.
* Have a clinically relevant current illness (within 4 weeks prior to dosing) or history of a medical condition that would interfere with the subject*s ability to complete the study or would confound the results of this study, as determined by the clinical investigator(s).;* Have a predisposing condition that could interfere with the absorption, distribution, metabolism, or excretion of drugs or any condition that may confound the analyses to be conducted in this study. ;* Have evidence of clinically relevant pathology.;* Have a clinically significant history of renal or hepatic disease or gastrointestinal disease.;* Have history of malignancy, suspicious or undiagnosed skin lesions, or a history of melanoma.;* Have history of psychoses, depression, suicidal ideation (as determined by CSSR assessment) or tendencies (within 1 year of the Screening Visit).;* Have past history of or current, severe cardiovascular or pulmonary disease, bronchial asthma, or endocrine disease including diabetes or hypoglycemia.;* Have history of lactose intolerance or lactose sensitivity. ;* Have a history of, or currently observed, clinically significant arrhythmias as evidenced on Screening ECG, or history of myocardial infarction that has residual atrial, nodal, or ventricular arrhythmias, or any other clinically significant cardiac disease ;* a systolic blood pressure of above 140 mm Hg or diastolic blood pressure of above 90 mm Hg or a systolic blood pressure of below 90 mm Hg or diastolic blood pressure of below 50 mm Hg.;* Have a history of, or currently observed, clinically significant CNS disorder.;* Have history of complications from venipunctures.;* Have donated blood or plasma within 60 days prior to the Screening Visit.;* Have a history of clinically significant alcohol or significant psychoactive substance use disorder (abuse, dependence, and/or withdrawal) within the past 12 months (within 1 year of the Screening Visit).;* Have a positive drug screen for drugs of abuse at Screening or upon admission.;* Have a positive test for human immunodeficiency virus (HIV), HAV IgM (to assess recent hepatitis A infection), hepatitis B, or hepatitis C.;* Have taken a prescription medication, including MOA inhibitors, within 14 days prior to the initial PK study period or taken over-the-counter oral preparations, including dietary and herbal supplements, 3 days prior to dosing.;* Previous exposure to USL260 or its metabolite. Have required continuation of previous concomitant medications other than those allowed (see Section X.X) during the study.;* Have participated in another clinical trial with any other investigational drug within 30 days prior to the first PK study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety, tolerability and pharmacokinetic profile.Food effect.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>