Infacort®と即時放出型ヒドロコルチゾンの薬物動態の比較
デキサメタゾンが抑制された健康な成人男性志願者を対象とした単一センター、非盲検、無作為化、クロスオーバー研究で、10 mg の単回投与で Infacort® 対即時放出ヒドロコルチゾン錠剤の薬物動態を比較し、用量での Infacort® の用量比例性を評価する0.5mg、2mg、5mg、10mgの
This was a single centre, open-label, randomised, 5-way crossover study.
調査の概要
詳細な説明
This was a single centre, open-label, randomised, 5-way crossover study design to compare the PK of Infacort® versus immediate-release hydrocortisone tablets and to evaluate the dose proportionality of 0.5 mg, 2 mg, 5 mg and 10 mg Infacort®. The study was conducted in 1 cohort of 16 healthy male subjects and comprised a Screening Visit, 5 treatment periods (Treatment Periods 1 to 5) and a Post-study Visit.
研究の種類
入学 (実際)
段階
- フェーズ 1
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 volunteers between 18 and 60 years of age, inclusive (at Screening Visit).
- Subjects with a Body Mass Index (BMI) of 21-28.
- Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days prior to the first dose of investigational medicinal product (IMP).
- Subjects with a negative urinary drugs of abuse screen determined within 14 days prior to the first dose of IMP. A positive alcohol test may have been repeated at the discretion of the Investigator.
- Subjects with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
- Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days prior to the first dose of IMP.
- Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
- Subjects (unless anatomically sterile or where abstaining from sexual intercourse was in-line with the preferred and usual lifestyle of the subject) and sexual partners used effective contraception methods during the trial and for 3 months after the last dose of IMP, for example; oral contraceptive + condom, intra-uterine device (IUD) + condom or diaphragm with spermicide + condom.
- Subjects were available to complete the study.
- Subjects satisfied a medical examiner about their fitness to participate in the study.
- Subjects provided 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 the first dose of IMP (including high dose vitamins, dietary supplements or herbal remedies).
- Receipt of any vaccination within 14 days prior to the first dose of IMP.
- 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).
- Participated 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 was 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 had consumed more than 2 units of alcohol per day within 7 days prior to the first dose of IMP or had consumed any alcohol within the 48 hr period prior to the first dose of IMP.
- Donation of 450 mL or more of blood within the previous 3 months.
- Subjects who smoked (or ex-smokers who had smoked within 6 months prior to first dose of IMP).
- Subjects who worked shifts (i.e. regularly alternated 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：基礎科学
- 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 |
|---|---|
|
実験的：Infacort 0.5 mg
Multi-particulate granules from 1 (0.5 mg) capsule |
Multi-particulate granules |
|
実験的：Infacort 2 mg
Multi-particulate granules from 1 (2 mg) capsule |
Multi-particulate granules |
|
実験的：Infacort 5 mg
Multi-particulate granules from 1 (5 mg) capsule |
Multi-particulate granules |
|
実験的：Infacort 10 mg
Multi-particulate granules from 1 (10 mg) capsule |
Multi-particulate granules |
|
アクティブコンパレータ：Hydrocortisone
1 (10 mg) tablet |
Tablet |
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 |
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Infacort vs Hydrocortisone
時間枠：-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
|
To compare the Cmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg. |
-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of Infacort vs Hydrocortisone
時間枠：-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
|
To compare the Tmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg. |
-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
|
|
Area Under the Curve (AUC0-t) of Infacort vs Hydrocortisone
時間枠：-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
|
To compare the AUC0-t of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg. AUC0-t represents the total exposure to drug over time, hence the reporting of a single value below. |
-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg
時間枠：-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
|
To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg. |
-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
|
|
Time to Maximum Plasma Concentration (Tmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg
時間枠：-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
|
To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg. |
-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h
|
|
Area Under the Curve (AUC0-t) of Infacort at Doses of 0.5, 2, 5 and 10 mg
時間枠：1 day
|
To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg. |
1 day
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Assessed by Medical Dictionary for Regulatory Activities (MedDRA) Dictionary, Version 16.0.
時間枠：1 day
|
To assess the safety and tolerability of Infacort® throughout the study. For a full list of TEAEs per arm, please refer to the Adverse Events section. |
1 day
|
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 001
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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