ヒドロコルチゾンの調査研究
健康な成人男性ボランティアにおけるヒドロコルチゾンおよび Infacort® の PK、経口バイオアベイラビリティ、および代謝パラメータとの関係を評価するための非盲検、部分無作為化、単回投与、クロスオーバー研究。
This study will investigate a new drug called Infacort®; a newly-developed immediate release formulation of a well-established drug called hydrocortisone. Hydrocortisone is used as a replacement treatment for people whose adrenal glands are not producing enough natural cortisol - a condition known as adrenal insufficiency. The study will assess how Infacort® acts once inside the body, by measuring cortisol and other hormone levels in the body, compared to already marketed hydrocortisone tablet and hydrocortisone intravenous (through the vein) injection.
The population who are eligible to take part in the study are healthy male volunteers, aged between 18 and 60 years of age.
調査の概要
状態
条件
詳細な説明
The study will evaluate the normal physiology, PK and metabolism of cortisol, investigate the PK and bioavailability of cortisol from the test Infacort® Granules (hydrocortisone) and the reference hydrocortisone tablets and i.v injection in healthy adult male volunteers and explore the role of cortisol in the regulation of metabolic pathways.
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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Merthyr Tydfil、イギリス、CF48 4DR
- Simbec Research Limited
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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:
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Healthy male volunteers between 18 and 60 years of age, inclusive (at screening).
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Subjects with a Body Mass Index (BMI) of 21-28. Body Mass Index = Body weight (kg) / (Height (m))*2.
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Subjects with no clinically significant abnormal serum biochemistry, haematology and urinalysis values within 14 days prior to Day 1 of Study Period 1.
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Subjects with a negative urinary drugs of abuse screen, determined within 14 days prior to Day 1 of Study Period 1. A positive alcohol test may be repeated at the discretion of the Investigator.
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Subjects with negative HIV and Hepatitis B and C results.
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Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days prior to Day 1 of Study Period 1.
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Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
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Subjects (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) and sexual partners must use effective contraception methods during the trial and for 3 months after the last dose, for example:
- Oral contraceptive + condom
- Intra-uterine device (IUD) + condom
- Diaphragm with spermicide + condom
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Subjects must be available to complete the study.
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Subjects must satisfy a medical examiner about their fitness to participate in the study.
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Subjects must provide written informed consent to participate in the study.
Exclusion Criteria:
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Receipt of regular medication within 14 days prior to Day 1 of Study Period 1 (including high dose vitamins, dietary supplements or herbal remedies).
- Receipt of any vaccination within 14 days prior to Day 1 of Study Period 1.
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Presence of clinically significant infections (systemic fungal and viral infections, acute bacterial infections).
- Current or previous history of tuberculosis.
- A clinically significant history of previous allergy / sensitivity to Hydrocortisone and/or Dexamethasone.
- A clinically significant history or family history of psychiatric disorders/illnesses.
- A clinically significant history of drug or alcohol abuse.
- Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
- Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. The washout period between trials is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study)
- Subjects who have consumed more than 2 units of alcohol per day within seven (7) days prior to Day 1 of Study Period 1or have consumed any alcohol within the 48 hour period prior to Day 1 of Study Period 1.
- Donation of 450ml or more of blood within the previous 3 months.
- Subjects who smoke (or ex-smokers who have smoked within 6 months prior to Day 1 of Study Period 1).
- Subjects who work shifts (i.e. regularly alternate between days, afternoons and nights).
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：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし：Endogenous Cortisol
No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. |
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他の：Dexamethasone
1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. Dexamethasone is considered a challenge agent and therefore a non-IMP |
Challenge agent
他の名前：
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実験的：Infacort®
20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous adrenocorticotropic Hormone (ACTH) and cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. |
Multi-particulate granules
他の名前：
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アクティブコンパレータ：Hydrocortisone Tablet
20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. |
Standard hydrocortisone tablets
他の名前：
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アクティブコンパレータ：i.v Hydrocortisone Injection
20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. |
Standard hydrocortisone solution for intravenous injection
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 |
|---|---|---|
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Maximum Serum Concentration (Cmax)
時間枠：Hourly from 0 to 24 hours
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Derived PK for Serum Cortisol: Maximum serum concentration (Cmax) |
Hourly from 0 to 24 hours
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AUC0-t
時間枠：Hourly from 0 to 24 hours
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Derived PK for Serum Cortisol: Area under the curve from 0-24 hours |
Hourly from 0 to 24 hours
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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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Adverse Events (AEs)
時間枠：Days 1-2 during each Study Period
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Number of subjects with adverse events throughout the study. |
Days 1-2 during each Study Period
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Concentrations of Cortisol Binding Protein
時間枠：Blood samples on Day 1 and/or Day 2 of each Study Period
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Cortisol protein binding under physiological conditions and after the administration of dexamethasone and hydrocortisone. |
Blood samples on Day 1 and/or Day 2 of each Study Period
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Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.
時間枠：Blood samples on Day 1 and/or Day 2 of each Study Period
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A standardised mixed meal elevates blood glucose and provides a reproducible stimulation of insulin release. Lower levels of insulin secretion, whilst maintaining normoglycaemia would indicate enhanced insulin sensitivity and glucose disposal; higher insulin levels will reflect insulin resistance. |
Blood samples on Day 1 and/or Day 2 of each Study Period
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PK and Metabolism of Cortisol
時間枠：Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period
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Blood: Serum cortisol under physiological conditions and after administration of dexamethasone and Infacort® Granules, Hydrocortisone Tablets and i.v Hydrocortisone Injection. |
Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period
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協力者と研究者
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 (推定)
学習記録の更新
投稿された最後の更新 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- Infacort 002
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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