A First Time in Human Study in Healthy Volunteers to Investigate a New Medicine to Treat Malaria
A Single-Blind, Placebo-Controlled, Randomized First Time in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Dose Escalation of GSK932121 in Healthy Adult Subjects
調査の概要
詳細な説明
Malaria is a type of parasitic infection, common in tropical and subtropical regions of the world, including parts of the Americas, Asia, and Africa. In recent years there has been a rapid spread of drug resistant malaria which makes it necessary to develop new antimalarial treatments. In animal studies, GSK932121 is shown to be able to kill the malaria parasite and is fully active against drug resistant malaria parasites. It is hoped that information collected on this study will lead to an improved treatment for malaria.
This is a first time in human fusion study which has 3 parts:
Part A - single dose escalation/ food effect: a study where the study drug is given once only- first at the lowest dose of in a group of participants and the dose increased only if the previous dose is found to be safe. It also looks at the effect of food on the study drug in the body Part B - repeat dose escalation: a study where the study drug will be given daily for up to 7 days - first at a lower dose in a group of participants and the dose increased for the next group only if the previous dose is found to be safe and Part B - drug-drug interaction: a study where the study drug will be given daily for up to 7 days at a dose determined to be safe in previous groups of participants and looking at the effect of the study drug on other specific approved medications (such as rosiglitazone--a diabetic medication and rosuvastatin--a cholesterol lowering medication) in the body.
Safety will be assessed by measurement of vital signs, cardiac monitoring, spirometry, collection of adverse event assessments, renal biomarkers and laboratory safety tests.
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
-
-
Victoria
-
Melbourne、Victoria、オーストラリア、3004
- GSK Investigational Site
-
-
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:
- Male or female between 18 and 50 years of age, inclusive
- Females of non-childbearing potential (as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
- Body weight > 50 kg and BMI within the range 19 - 31 kg/m2 (inclusive)
- QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block
Exclusion Criteria:
- Positive pre-study drug/alcohol screen
- Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for HIV antibody
- History of regular alcohol consumption within 6 months of the study
- Participation in a clinical trial with an investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer) prior to start of the new study
- Exposure to more than four new drugs or within 12 months prior to the first dosing day
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that would be contraindicated
- Donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- History of sensitivity to heparin or history of heparin-induced thrombocytopenia if heparin is used to maintain the patency of an intravenous cannula.
- Asthma or a history of asthma
- Smoking or history or regular use of tobacco- or nicotine-containing products within 2 months prior to screening
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
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:クロスオーバー割り当て
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Single Dose, Repeat Dose, Drug-Drug Interaction
GSK932121 or placebo will be administered as a single dose with or without food in a dose escalation manner. Once the results from the single dose is obtained and reviewed, GSK932121 or placebo will be administered as a repeat dose. The results from each repeat dose level will be reviewed prior to determining the next repeat dose level. To better understand the effect of GSK932121 on rosiglitazone and rosuvastatin, a drug-drug interaction arm will also be investigated in this study. Rosiglitazone and rosuvastatin will be administered alone, then GSK932121 will be given as a repeat dose. Rosiglitazone and rosuvastatin will then be administered in combination with GSK932121. |
GSK932121 is the study drug that will be tested in all parts of this study as described above.
Rosiglitazone and rosuvastatin will only be tested in the drug-drug interaction substudy.
|
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 |
|---|---|
|
Evidence of safety as determined by assessing adverse events, vital signs, spirometry, ECGs, telemetry, renal biomarkers, safety labs, and physical examination
時間枠:Part A: 3-4 months; Part B: ~1 month
|
Part A: 3-4 months; Part B: ~1 month
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Plasma or blood concentrations of study drug
時間枠:Part A: 3-4 months; Part B: ~1 month
|
Part A: 3-4 months; Part B: ~1 month
|
協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
- 111319
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?
IPD プランの説明
試験データ・資料
-
研究プロトコル
情報識別子:111319情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
-
インフォームド コンセント フォーム
情報識別子:111319情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
-
統計分析計画
情報識別子:111319情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
-
データセット仕様
情報識別子:111319情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
-
注釈付き症例報告書
情報識別子:111319情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
-
臨床研究報告書
情報識別子:111319情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
-
個人参加者データセット
情報識別子:111319情報コメント:For additional information about this study please refer to the GSK Clinical Study Register
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。