A Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers
A Randomized, Double-Blind, Placebo-Controlled, Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers
調査の概要
詳細な説明
This study was designed as a randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to assess the safety and pharmacokinetics of supratherapeutic doses of eslicarbazepine acetate in 32 healthy adult male and female subjects, with 8 subjects per treatment group. In each study group, subjects were to receive single doses of eslicarbazepine acetate or placebo once daily for 5 days.
A series of screening evaluations was performed within a 21-day period prior to the first dose of study medication in order to determine the eligibility of prospective study participants for the trial. Eligible subjects reported to the clinic on Day -1 prior to study medication administration and remained in the clinic until clinic discharge on Day 7. Plasma and urine samples were collected throughout the study to determine the pharmacokinetics of eslicarbazepine acetate and its metabolites.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Florida
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Miramar、Florida、アメリカ、33025
- Comprehensive Phase OneTM
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Healthy male or female 18 to 45 years of age. Women were required to be postmenopausal (more than 12 months since last period); surgically sterile (hysterectomy or tubal ligation at least 6 months prior to enrollment); using an intrauterine device; or double barrier (i.e. diaphragm or spermicide plus male condom) non-hormonal contraceptive therapy for the duration of the trial. Female subjects were required to have a negative pregnancy test at screening and upon check-in to the study facility.
- BMI within the range of 18-30 kg/m2.
- Ability to communicate effectively with the study personnel.
- No significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit and on admission to the clinic.
- Normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction.
- Nonsmokers defined as not having smoked in the past 6 months.
- Subjects were to be adequately informed of the nature and risks of the study and were required to provide written informed consent prior to study entry.
Exclusion Criteria:
- Known hypersensitivity or allergy to eslicarbazepine acetate or related compounds such as carbamazepine, oxcarbazepine, or licarbazepine.
- Women who were pregnant or breast feeding.
- Any disease or condition (medical or surgical) which, in the opinion of the investigator, had the potential to compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that could interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk.
- A sustained supine systolic blood pressure > 140 mmHg or <100mmHg or a diastolic blood pressure > 95 mmHg at screening or baseline.
- A resting ECG heart rate of <50 bpm or >100 bpm.
- An abnormal screening ECG indicating a second- or third-degree AV block, or one or more of the following: QRS > 110 milliseconds (msec), QTc (Fridericia correction) > 450 msec, PR interval > 240 msec. Any rhythm other than sinus rhythm, which was interpreted by the Investigator to be clinically significant.
- The presence of abnormal laboratory values which were considered clinically significant.
- Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1 or 2).
- Receipt of an investigational drug within a period of 30 days prior to enrollment in the study.
- Receipt of any drug therapy, including hormonal contraceptives, within 2 weeks prior to administration of the first dose of any study-related treatment. This exclusion was extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism.
- Consumption of alcohol within 48 hours prior to dose administration or during any in-patient period.
- A positive urine drug screen including ethanol, cocaine, THC, barbiturates, amphetamines, benzodiazepines, and opiates.
- Any history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction.
- A history of difficulty with donating blood.
- Donation of blood or blood products within 45 days prior to enrollment.
- Subjects with, or with a history of, additional risk factors for Torsades de Points (e.g., heart failure, hypokalemia), or a family history of long QT syndrome or family history of sudden death.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター:Placebo
Matching placebo tablets for oral administration
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経口投与に適したプラセボ錠剤
他の名前:
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実験的:BIA 2-093 3000 mg once daily
Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)
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Eslicarbazepine acetate 600 mg tablets for oral administration
他の名前:
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実験的:BIA 2-093 3600 mg once daily
Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)
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Eslicarbazepine acetate 600 mg tablets for oral administration
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of Adverse Events Reported
時間枠:2 days
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Safety was evaluated through the recording and monitoring of adverse events
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2 days
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- BIA-2093-118
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プラセボの臨床試験
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Palacky University完了
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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
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Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
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University Hospital, Strasbourg, France積極的、募集していない