A Comparison Of Study Drug Blood Levels After One Dose Of GSK189075 In Subjects With Normal And Reduced Kidney Function
2012年3月15日 更新者:GlaxoSmithKline
An Evaluation of the Pharmacokinetics of a Single Oral Dose of GSK189075 in Patients With Varying Degrees of Renal Insufficiency Compared to Volunteers With Normal Renal Function
This is an open-label study that will measure blood levels of different parts of a drug called GKS189075.
People participating in this study will receive a single dose of 250mg GSK189075 by mouth.
About 20 people with mild to moderate decrease in renal (kidney) function will be asked to participate in this study.
They will be compared to about 20 healthy participants who are close to the same age and body size.
People participating in this study will stay at a clinical research unit beginning 2 days before they receive their single dose of GSK189075 and will remain there until approximately one day after receiving the study drug.
During this study urine will be collected beginning the day before receiving study drug until the day after, just prior to leaving the clinical research unit.
Blood samples will also be collected at various times beginning immediately before until 24 hours after receiving the study drug.
調査の概要
研究の種類
介入
入学 (実際)
29
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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Florida
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Orlando、Florida、アメリカ、32809
- GSK Investigational Site
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Minnesota
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Minneapolis、Minnesota、アメリカ、55404
- GSK Investigational Site
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Tennessee
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Knoxville、Tennessee、アメリカ、37920
- GSK Investigational Site
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Texas
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Austin、Texas、アメリカ、78752
- GSK Investigational Site
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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~75年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- A female is eligible to enter and participate in this study if she is of Non-child-bearing potential with a negative pregnancy test at screening or of Childbearing potential, has a negative serum pregnancy test at screening, is not lactating, and agrees to adequate contraception.
- Satisfactory medical evaluation based upon medical history, medication history, physical examination, and clinical laboratory data obtained at the Screening visit.
- Body weight > 50 kg. BMI within the range of 19 to 40 kg/m2.
- Signed and dated written informed consent prior to participation in any protocol-specific procedures, including screening procedures.
- The subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.
- Additional Inclusion Criteria for Subjects with Renal Insufficiency: Subjects with renal insufficiency must be considered by the investigator to be clinically stable. Subjects must continue to meet this criterion of stable renal function upon check-in into the clinic
Exclusion Criteria:
- History of regular alcohol consumption averaging >7 drinks per week for women or >14 drinks per week for men within 6 months of Screening. One drink is equivalent to 12 g alcohol = 5 ounces (oz; 150 ml) of wine or 12 oz (360 ml) of beer or 1.5 oz (45 ml) of 80 proof distilled spirits.
- A positive drug or alcohol test at Screening or Check-in.
- Smokers will be allowed to enrol in the study; however, smoking that interferes with the collection/recording of ongoing study procedures will not be allowed. Smoking status will be recorded in the CRF.
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication for the current study.
- The subject has donated more than 450mL blood within the 56 day period prior to the first scheduled administration of GSK189075.
- Known or suspected gastroparesis, gastric surgery within the 6 months prior to screening, or any other gastrointestinal condition that would likely interfere with absorption of GSK189075.
- Subjects with clinical laboratory values outside rages as specified in the protocols
- Any subject with either documented cirrhosis or a history consistent with a diagnosis of cirrhosis.
- Urinary tract or bladder infection within 4 weeks of the first scheduled administration of study drug.
- Positive hepatitis B surface antigen, or HIV at Screening. If negative test results have been documented within the last 2 months, it will not be necessary to repeat these tests. Subjects with positive results for hepatitis C antibodies may be eligible if they have normal liver enzymes and no history of hepatitis and are approved by the GSK medical monitor.
- Any history of myocardial infarction, cardiac syncope.
- A history of clinically significant cardiac arrhythmias (individual cases to be discussed with the GSK Medical Monitor).
- A history of unstable angina in the past 6 months.
- Cardiac conduction abnormalities denoted by ranges specified in the protocol
- Systolic blood pressure < 80 mmHg or > 180 mmHg
- Diastolic blood pressure < 60 mmHg or > 100 mmHg
- Use of prescription or non-prescription drugs (including high dose vitamins, herbal and dietary supplements [including St. John's Wort]) within 7 days prior to administration of the first dose of study medication, unless in the opinion of the investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety. Some allowable exceptions are found in the Permitted Medications section (Section 9.1).
Additional Exclusion Criteria for Subjects with Renal Insufficiency
- Patients on a new drug regimen (defined as starting a new drug or changing dosage regimen of a current drug within 7 days prior to administration of GSK189075). No restrictions will be placed on the use of insulin, 1,25 dihydroxyvitamin D3 (Rocaltrol), erythropoietin, and calcium- or aluminum-containing phosphate binders.
- Subjects whose current medication therapy is not in agreement with the information provided in Sections 9.1, 9.2, or 9.3 of this protocol.
- Serum albumin less than 2.5 g/dL.
- Hemoglobin less than 8.5 g/dL. Additional Exclusion Criteria for Subjects with Normal Renal Function
- Any clinically relevant abnormality identified on the screening physical or laboratory examination. Any abnormalities of outside the normal reference range at Screening may be repeated once and must be reviewed with the GSK Medical Monitor prior to enrollment of a subject into the study.
- Hemoglobin or hematocrit below the reference range at Screening
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:非ランダム化
- 介入モデル:並列代入
- 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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他の:Mild renal impairmnent
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single 250 mg dose of drug
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他の:moderate renal impairment
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single 250 mg dose of drug
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他の:Normal renal function
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single 250 mg dose of drug
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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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drug & metabolite plasma levels
時間枠:at 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, & 24 hours after dosing
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at 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, & 24 hours after dosing
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二次結果の測定
結果測定 |
時間枠 |
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urine levels of Glucose & electrolytes, Drug & metabolites
時間枠:at 0-6, 6-12 & 12-24 hours after dosing
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at 0-6, 6-12 & 12-24 hours after dosing
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ECG, labs, vital signs, adverse events
時間枠:each visit
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each visit
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Plasma protein binding of GSK189074 and GSK279782
時間枠:2 hr
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2 hr
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GSK189074 and GSK279782 in 24 hour urine collection and corresponding renal clearance CLr.
時間枠:24 hr
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24 hr
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urine glucose excreted.
時間枠:6, 12, 24 hours
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6, 12, 24 hours
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Urinary creatinine clearance (CLcr).
時間枠:6, 12, 24 hours
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6, 12, 24 hours
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Safety and tolerability parameters, including AEs and clinically relevant changes in vital signs (heart rate and blood pressure), ECGs, urine electrolytes, and clinical laboratory assessments (clinical chemistry, hematology, and urinalysis).
時間枠:1, 2, 4, 12, 24 hours
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1, 2, 4, 12, 24 hours
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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
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
2007年7月1日
一次修了 (実際)
2008年3月1日
研究の完了 (実際)
2008年3月1日
試験登録日
最初に提出
2007年7月13日
QC基準を満たした最初の提出物
2007年7月13日
最初の投稿 (見積もり)
2007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)
2012年3月19日
QC基準を満たした最後の更新が送信されました
2012年3月15日
最終確認日
2011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。
2型糖尿病の臨床試験
GSK189075の臨床試験
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GlaxoSmithKline完了2型糖尿病アメリカ, カナダ, ドイツ, エストニア, ロシア連邦, 南アフリカ, インド, ウクライナ, メキシコ, ギリシャ, ニュージーランド, ポーランド, チェコ, リトアニア, ルーマニア, プエルトリコ
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GlaxoSmithKline完了2型糖尿病アメリカ, アルゼンチン, ポーランド, ドイツ, ブルガリア, ペルー, ロシア連邦, メキシコ, ハンガリー, 南アフリカ, ラトビア, ニュージーランド, コスタリカ, インド, チェコ, ルーマニア, リトアニア, プエルトリコ, チリ
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GlaxoSmithKline完了