A comparative, open label, randomized, 2 periods, 2 sequence crossover study to assess the relative bioavailability of sodium oxybate for extended release oral suspension (FT218) formulation (single dose administered at the dose of 6g) versus the marketed reference Xyrem® (at the dose of 2 x 3g ) in healthy volunteers.

Flamel Ireland Ltd trading under the business name Avadel Ireland0 个研究点目标入组 24 人开始时间: 2017年10月17日最近更新: 2019年6月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 24

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

入选标准

•The following inclusion criteria must be met for a subject to be eligible for inclusion in the study:
•1. Gender:male or female; females may be of childbearing potential, of non childbearing potential, or postmenopausal
•2. Age: 18-65 years, inclusive, at screening
•3. Body mass index (BMI) : 18.0-28.0 kg/m2
•4. Weight : =60 kg
•5. Status: healthy subjects
•6. Race/Ethnicity: White” (Caucasian)/Not Hispanic or Latino”
•7. Female subjects must be:
•postmenopausal for at least 1 year before the screening visit with follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status, as per PI judgment, OR
•surgically sterile, OR
•if of childbearing potential, agree to practice at least one highly effective method of contraception from the time of signing informed consent through 90 days after the last dose of study drug or complete abstinence during the study if in line with the preferred and usual lifestyle of the subject.
•Birth control methods considered as highly effective include:
•o Combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal
•o Progesterone-only hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal
•o Hormonal or copper intrauterine device
•o Bilateral tubal occlusion
•o Vasectomized partner
•8. Female subjects of childbearing potential must be non-pregnant and non lactating, and have a negative pregnancy test at screening and each admission to the clinical research center
•9. Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject is defined as using hormonal contraceptives or an intrauterine device by his female partner. Also, total abstinence, in accordance with the lifestyle of the subject is acceptable
•10. Normal blood pressure and heart rate (HR) at the screening visit after 5 minutes in supine position:
•95 mmHg = systolic blood pressure (SBP) = 140 mmHg
•50 mmHg = diastolic blood pressure (DBP) = 90 mmHg
•45 beats per minute (bpm) = HR = 90 bpm
•Or considered as not clinically significant as per PI judgment
•11. Normal ECG recording on a 12-lead ECG
•120 < PR < 210 ms
•QRS < 120 ms
•QTc-interval (Fridericia’s) = 430 ms for male and < 450 ms for female
•No signs of sick sinus syndrome
•Or considered as not-clinically significant as per PI judgment
•12. Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged

排除标准

•A subject who meets any of the following exclusion criteria will not be eligible for inclusion in the study:
•1. Employee of PRA or the Sponsor
•2. The presence of any unstable or clinically significant medical or psychiatric disorders (as determined by medical or psychiatric history, physical examination, and/or clinical laboratory test) which in the opinion of the PI may either put the subject at risk by participation in the study, or may influence the results of the study
•3. History of seizure, head trauma, or past-intracranial surgery
•4. Any finding in the medical history, physical examination or clinical laboratory tests giving reasonable suspicion of a disease that would contraindicate taking FT218, or a known poor tolerability to the active compound
•5. Subjects with a previous history or current ideation of suicide attempt
•6. Subjects with a medical diagnosis of Major Depression, as defined by the DSM-IV Criteria for Major Depression Disorder, which in the opinion of the PI would impact subject safety and place the subject at risk by participation in the study
•7. Subjects with an O2 saturation of less than 95% at screening or first admission, as measured by pulse oximetry (on room air while fully awake), or subjects with known or suspected respiratory difficulty or any condition that may compromise a subject’s breathing or ability to maintain adequate O2 saturation.
•8. Subjects diagnosed with sleep apnea or at high risk for sleep apnea, reporting a history of loud snoring (louder than talking or loud enough to be heard through closed doors), or observed to stop breathing during sleep.
•9. Subjects who have a history of drug or alcohol use that, in the opinion of the PI would interfere with study subject safety and adherence to study requirements
•10. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)
•11. Occurrence of heartburn, or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs
•12. Frequent headaches and/or migraine, recurrent nausea and/or vomiting
•13. Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP = 20 mmHg within 2 minutes when changing from the supine to the standing position
•14. Donation or loss of more than 100 mL of blood within 60 days prior to the first drug administration. Donation or loss of more than 1.5 liters of blood (for men) / more than 1.0 liters of blood (for women) in the 10 months prior to the first drug administration in the current study
•15. General anesthesia scheduled during the study
•16. Known contraindication/allergy/sensitivity/intolerance to the study drug, sodium oxybate, or the inactive ingredients of FT218
•17. Subject who c

研究者

发起方

Flamel Ireland Ltd trading under the business name Avadel Ireland

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A COMPARATIVE, OPEN-LABEL, RANDOMIZED, 2 PERIODS, 2 SEQUENCES CROSSOVER STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY OF SODIUM OXYBATE FOR EXTENDED RELEASE ORAL SUSPENSION (FT218) FORMULATION (SINGLE DOSE ADMINISTERED AT THE DOSE OF 6 G) VERSUS THE MARKETED REFERENCE XYREM® (AT THE DOSE OF 2*3 G) IN HEALTHY VOLUNTEERSCataplexyNarcolepsy10040998

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