Phase I Study in Healthy Male Subjects Comparing QGC001 to Placebo
2013年7月11日 更新者:Quantum Genomics SA
A Phase I, Double-blind, Placebo-controlled, Ascending Single-dose, Safety, Tolerability and Pharmacokinetic Study of QGC001 in Healthy Male Subjects.
QGC001/1QG1 is a Phase I "first time in man" study aiming to determine the overall safety and tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system, blood pressure and heart rate) in healthy male subjects.
調査の概要
研究の種類
介入
入学 (実際)
56
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
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Rueil-Malmaison、フランス、92502
- Biotrial PARIS
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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
男
説明
Inclusion Criteria:
- Caucasian, male healthy subjects of 18 to 45 years of age.
- Body weight ≥50 kg, with a body mass index calculated as weight in kg/(height in m2) from 18 to 27 kg/m2 at screening.
- Subjects will sign and date an informed consent form before any study-specific screening procedure is performed.
- Healthy, as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings.
- Non-smoker or smoker of fewer than 5 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
- Have a high probability for compliance with and completion of the study.
Exclusion Criteria:
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy.
- Acute disease state within 7 days before study day 1.
- History of drug abuse within 1 year before study day 1.
- History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day.
- Positive serologic findings for human immunodeficiency virus antibodies, hepatitis B surface antigen, and/or hepatitis C virus antibodies.
- Positive findings of urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA)
- History of any clinically important drug allergy.
- Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product administration.
- Consumption of any caffeine-containing products in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
- Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before investigational medicinal product administration.
- Donation of blood (i.e. 450 ml) within 90 days before study day 1.
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
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:10 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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実験的:50 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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実験的:125 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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実験的:250 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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実験的:500 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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実験的:750 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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実験的:1,000 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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実験的:1,250 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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プラセボコンパレーター:Placebo
The placebo was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
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ステアリン酸マグネシウム、歯科用シリカ、無水乳糖が含まれています。
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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 |
時間枠 |
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Adverse events
時間枠:up to 11 days
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up to 11 days
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Blood pressure
時間枠:up to 11 days
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up to 11 days
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Heart rate
時間枠:up to 11 days
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up to 11 days
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Body temperature
時間枠:up to 11 days
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up to 11 days
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12-lead ECG
時間枠:up to 11 days
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up to 11 days
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Red blood cell count
時間枠:up to 11 days
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up to 11 days
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Haemoglobin
時間枠:up to 11 days
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up to 11 days
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Haematocrit
時間枠:up to 11 days
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up to 11 days
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White blood cell count with differential
時間枠:up to 11 days
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up to 11 days
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Platelet count
時間枠:up to 11 days
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up to 11 days
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Plasma sodium
時間枠:up to 11 days
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up to 11 days
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Plasma potassium
時間枠:up to 11 days
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up to 11 days
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Plasma calcium
時間枠:up to 11 days
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up to 11 days
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Plasma total bilirubin
時間枠:up to 11 days
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up to 11 days
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Plasma conjugated bilirubin
時間枠:up to 11 days
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up to 11 days
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Plasma Aspartate Amino Transferase (ASAT)
時間枠:up to 11 days
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up to 11 days
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Plasma Alanine Amino Transferase (ALAT)
時間枠:up to 11 days
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up to 11 days
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Plasma Gamma Glutamyl Transferase (GGT)
時間枠:up to 11 days
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up to 11 days
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Plasma alkaline phosphatases
時間枠:up to 11 days
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up to 11 days
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Plasma total protein
時間枠:up to 11 days
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up to 11 days
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Plasma Creatine PhosphoKinase (CPK)
時間枠:up to 11 days
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up to 11 days
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Plasma creatinine
時間枠:up to 11 days
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up to 11 days
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Plasma glucose
時間枠:up to 11 days
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up to 11 days
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Plasma cholesterol
時間枠:up to 11 days
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up to 11 days
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Plasma triglycerides
時間枠:up to 11 days
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up to 11 days
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Urinary pH
時間枠:up to 11 days
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up to 11 days
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Urinary protein
時間枠:up to 11 days
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up to 11 days
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Urinary glucose
時間枠:up to 11 days
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up to 11 days
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Urinary leukocytes
時間枠:up to 11 days
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up to 11 days
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Urinary nitrites
時間枠:up to 11 days
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up to 11 days
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Urinary ketones
時間枠:up to 11 days
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up to 11 days
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Urinary blood
時間枠:up to 11 days
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up to 11 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Maximum observed plasma concentration (Cmax) of QGC001
時間枠:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Time at which Cmax is observed (tmax) of QGC001
時間枠:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Elimination rate constant (λz) of QGC001
時間枠:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Terminal half-life (t1/2,z) of QGC001
時間枠:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Area Under the Concentration-time curve (AUClast and AUC0-∞) of QGC001
時間枠:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Maximum observed plasma concentration (MRCmax) of metabolic ratios
時間枠:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Area Under the Concentration-time curve (MRAUC) of metabolic ratios
時間枠:H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
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Cumulative amount eliminated (Ae)
時間枠:H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
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H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
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Fraction recovered (Fe)
時間枠:H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
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H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
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Renal clearance (CLR)
時間枠:H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
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H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
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Plasma renin
時間枠:H-1 pre-dose and H2, H4 and H9 post-dose
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Determination of renin in blood samples.
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-1 pre-dose and H2, H4 and H9 post-dose
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Plasma aldosterone
時間枠:H-1 pre-dose and H2, H4 and H9 post-dose
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Determination of aldosterone in blood samples.
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-1 pre-dose and H2, H4 and H9 post-dose
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Plasma cortisol
時間枠:H-1 pre-dose and H2, H4 and H9 post-dose
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Determination of cortisol in blood samples.
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-1 pre-dose and H2, H4 and H9 post-dose
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Plasma copeptin
時間枠:H-1 pre-dose and H2, H4 and H9 post-dose
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Determination of copeptin in blood samples (if possible, will be determined later).
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-1 pre-dose and H2, H4 and H9 post-dose
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Urinary aldosterone
時間枠:H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
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Aldosterone analysis in urine samples.
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
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Urinary cortisol
時間枠:H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
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Cortisol analysis in urine samples.
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
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Urinary creatinin
時間枠:H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
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Creatinin analysis in urine samples.
In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
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H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
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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。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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
2012年2月1日
一次修了 (実際)
2012年5月1日
研究の完了 (実際)
2012年5月1日
試験登録日
最初に提出
2013年6月26日
QC基準を満たした最初の提出物
2013年7月11日
最初の投稿 (見積もり)
2013年7月16日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年7月16日
QC基準を満たした最後の更新が送信されました
2013年7月11日
最終確認日
2013年7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。
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