Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers
2015年6月19日 更新者:Lee's Pharmaceutical Limited
A Phase I Dose Escalating Study Evaluating the Pharmacokinetics, Tolerability and Safety of Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers
Phase 1 study to investigate safety of istaroxime in healthy chinese volunteers.
調査の概要
詳細な説明
32 subjects (F: M=1:1) were randomized in three dose groups (0.25-0.5-1.0ug/kg/min).
8 subjects in 0.25ug/kg/min group were administrated Istaroxime + 0.9% NS; 12 subjects in 0.5ug/kg/min or 1.0 ug/kg/min group randomly received Istaroxime placebo + 0.9% NS (2 subjects), 0.9% NS alone (2 subjects) and Istaroxime + 0.9% NS (8 subjects).
All the subjects were given infusion of study drugs for 24 hours, and then were observed for 48 hours in the clinic.
At least 1 week should be kept between two dose groups.
Escalation to the higher dose will occur after the lower dose group has been completed and no significant safety issues are found.
研究の種類
介入
入学 (予想される)
32
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Beijing、中国、100071
- 募集
- The 307th Hospital of Chinese People's Liberation Army
-
コンタクト:
- Ruihua Dong, MD
- 電話番号:+86-10-66947798
-
コンタクト:
- Hengyan Qu, MD
- 電話番号:+86-10-66947798
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~45年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age at 18-45 years (inclusive)
- Male or Non-pregnant, non-lactating women
- Chinese healthy subjects
- Body mass index (BMI) at 19-24 kg/m2 (inclusive) and body weight at 50-100kg
- Lab examinations (include but not limited: Hemoglobin, white blood cell counting, differential count, creatinine,Alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT),Total bilirubin and urinalysis) are within normal range or out of normal range but no clinical significance.
- Vital signs in screening phase: SBP100-139mmHg, DBP 50-89 mmHg, pulse rate 45-90 bpm. Holter is within normal range or out of normal range but no clinical significance.
- Both physical examination and ECG at baseline are normal or abnormal but no clinical significance
- Women of childbearing age during the trial must be willing to use a medically acceptable method of contraception, which include surgical sterilization (tubal ligation / hysterectomy), and double barrier methods of hormonal contraception.
- Subjects well communicate with investigators, understanding the requirements of investigators and being willing to sign the ICF before conducting any study-related procedure.
- Subjects are willing to stay at the phase I ward throughout the study.
Exclusion Criteria:
- Disease history in liver, kidney, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal tract, lungs, immune, skin, blood, or metabolic disorders or cancer, that may have great impact on the study results.
- Presence of pancreatitis, intestinal obstruction, glaucoma, prostatic hypertrophy, adrenal disease, hyperthyroidism or gallbladder disease (subjects had experienced cholecystectomy will not be excluded)
- History of clinical significant disease in the past 4 weeks before screening visit
- Presence of diseases which are known to disturb the absorption, distribution, metabolism or excretion of Istaroxime
- Physical examinations, medical history, ECG, vital signs or lab examination are deemed to be abnormal and clinical significant
- Be intolerant or allergy to Istaroxime, lactose or any similar substances
- Significantly abnormal diets are conducted within 4 weeks before screening visit
- Blood donation or loss equal to or exceeds 400ml in the past 6 months
- Participating in the any other drug study in the past 3 months
- Administrated OTC drugs including vitamin supplements and herbal (Occasional use of paracetamol will not be excluded)
- Regular use of any prescription drug (Hormonal birth control pills or hormone replacement therapy will not be excluded)
- Drinking beverage or eat food containing caffeinated / xanthine or poppy seed since 48 hours before study drugs administration; or drinking beverage or eat food containing grapefruit, oranges or Chinese tea 14 days before the study drug administration
- Receiving the therapy of drugs including cytochrome P450 3A4 or cytochrome P450 2C8 inhibitors or inducers (eg barbiturates, carbamazepine, erythromycin, phenytoin, thiazoline TZDs, Rifampin)
- Women at Lactation period or with positive pregnancy test
- Tongue piercing or lip piercing occurred 30 days before the study drug administration
- Smoke or tobacco is used 60 days before the study drug administration
- History of abusing any substance including infusion drugs, alcohol and opium
- Positive alcohol breathing test within 1day or drink alcohol within 1week
- Abusing drugs (include Opioids, oxycodone, methamphetamine, amphetamine, cannabinoids, cocaine, barbiturates, benzodiazepines class, methadone, buprenorphine and phencyclidine)
- History of heart disease
- Planning to be pregnant in the recent 3 months
- Participating any other interventional strudy in the past 30 days
- History of bronchial asthma or blood porphyria disease
- HbsAg, anti-HCV, anti-HIV or anti - syphilis are positive
- Holter examination is abnormal and clinical significant
- Subjects are not eligible for the study judged by investigators
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:low dose group
8 subjects in 0.25ug/kg/min group were administrated Istaroxime + 0.9% NS; All the subjects were given infusion of study drugs for 24 hours, and then were observed for 48 hours in the clinic.
|
8 subjects in 0.25ug/kg/min group were administrated Istaroxime + 0.9% NS fo12 subjects in 0.5ug/kg/min or 1.0 ug/kg/min group randomly received Istaroxime placebo + 0.9% NS (2 subjects), 0.9% NS alone (2 subjects) and Istaroxime + 0.9% NS (8 subjects).
|
実験的:mid dose group
12 subjects in 0.5ug/kg/min group randomly received Istaroxime placebo + 0.9% NS (2 subjects), 0.9% NS alone (2 subjects) and Istaroxime + 0.9% NS (8 subjects).
All the subjects were given infusion of study drugs for 24 hours, and then were observed for 48 hours in the clinic.
|
8 subjects in 0.25ug/kg/min group were administrated Istaroxime + 0.9% NS fo12 subjects in 0.5ug/kg/min or 1.0 ug/kg/min group randomly received Istaroxime placebo + 0.9% NS (2 subjects), 0.9% NS alone (2 subjects) and Istaroxime + 0.9% NS (8 subjects).
infusion for 24 hours
|
実験的:high dose group
12 subjects in 1.0 ug/kg/min group randomly received Istaroxime placebo + 0.9% NS (2 subjects), 0.9% NS alone (2 subjects) and Istaroxime + 0.9% NS (8 subjects).
All the subjects were given infusion of study drugs for 24 hours, and then were observed for 48 hours in the clinic.
|
8 subjects in 0.25ug/kg/min group were administrated Istaroxime + 0.9% NS fo12 subjects in 0.5ug/kg/min or 1.0 ug/kg/min group randomly received Istaroxime placebo + 0.9% NS (2 subjects), 0.9% NS alone (2 subjects) and Istaroxime + 0.9% NS (8 subjects).
infusion for 24 hours
|
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 |
---|---|---|
safety of istaroxime in healthy volunteers is measured by varition of heart functon, blood pressure and heart ratio
時間枠:one week
|
safety of istaroxime in healthy volunteers is measured by
|
one week
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年5月1日
一次修了 (予想される)
2015年7月1日
研究の完了 (予想される)
2015年8月1日
試験登録日
最初に提出
2015年6月17日
QC基準を満たした最初の提出物
2015年6月19日
最初の投稿 (見積もり)
2015年6月22日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年6月22日
QC基準を満たした最後の更新が送信されました
2015年6月19日
最終確認日
2015年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。