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A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose

2019年4月30日 更新者:Mirum Pharmaceuticals, Inc.

A Phase 1, Open-label Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of [14C]-SHP626 Following a Single Oral Dose in Healthy Male Subjects

The purpose of this study is to determine how SHP626 is absorbed and excreted from the body in healthy males.

調査の概要

研究の種類

介入

入学 (実際)

8

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

    • Wisconsin
      • Madison、Wisconsin、アメリカ、53704
        • Covance Madison Clinical Research Unit

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~50年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

説明

Inclusion Criteria:

  1. Age between 18 and 50 years, inclusive, at the time of consent.
  2. Must be considered healthy. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, thyroid panel (includes T3, T4 and TSH at Screening only), blood chemistry, coagulation and urinalysis
  3. Must have a body mass index between 18.0-30.0kg/m² inclusive with a body weight >50 kg (110 lbs).
  4. Ability to swallow all investigational product.
  5. A minimum of 1 bowel movement per day.

Exclusion Criteria:

  1. History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gallbladder removal, gastric bypass surgery, ileal resection, any small intestinal resection,or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
  2. Current or relevant history of physical or psychiatric illness.
  3. Known or suspected intolerance or hypersensitivity to the investigational product, or closely-related compounds, or any of the stated ingredients.
  4. Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.
  5. Known history of alcohol or other substance abuse within the last year.
  6. Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the dose of investigational product.
  7. Within 30 days prior to the dose of investigational product:

    • Have used an investigational product (if elimination half-life is <6 days, otherwise 5 half-lives).
    • Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
    • Have had any substantial changes in eating habits, as assessed by the investigator.
  8. Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
  9. Twelve-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450msec, the ECG should be repeated 2 more times and the average of the 3 QTc values should be used to determine the subject's eligibility.
  10. A positive screen for drugs of abuse at Screening or a positive screen for alcohol or drugs of abuse at Check-in (Day -1).
  11. Male subjects who consume more than 21 units of alcohol per week or 3 units of alcohol per day.
  12. A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody screen.
  13. Use of tobacco in any form
  14. Routine consumption of more than 2 units of caffeine per day
  15. Current use of any medication including over-the-counter, herbal, or homeopathic preparations
  16. An inability to follow a standardized diet and meal schedule or inability to fast
  17. Have participated in a [14C]-study within the last 6 months prior to the dose of investigational product.
  18. Exposure to clinically significant radiation within 12 months prior to the dose of investigational product

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:基礎科学
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • 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:Experimental Drug
single oral dose radiolabelled 50mg of SHP626
single oral dose 50mg SHP626 with approximately 5.95 μCi RAD

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
Pharmacokinetic parameters will be determined from the plasma and blood concentration time data of total radioactivity and from the plasma concentration-time data for SHP626 by non-compartmental analysis.
時間枠:Day 1 to day 10
Day 1 to day 10
Total radioactivity (RAD) in whole blood and plasma
時間枠:Day 1 to day 10
Day 1 to day 10
To determine the total RAD in urine and feces.
時間枠:Day 1 to day 10
Day 1 to day 10
Maximum plasma concentration (Cmax) of 50mg [14C]-SHP626 and RAD occurring at time of maximum observed concentration (tmax)
時間枠:Day 1 to day 10
Day 1 to day 10
Area under the plasma concentration curve (AUC0-t) of 50mg [14C]-SHP626 and RAD from the time of dosing to the last measurable concentration
時間枠:Day 1 to Day 10
Day 1 to Day 10
Area under the plasma concentration curve (AUC0-∞ ) of 50mg [14C]-SHP626 and RAD extrapolated to infinity, calculated using the observed value of the last non-zero plasma concentration
時間枠:Day 1 to Day 10
Day 1 to Day 10
First order rate constant associated with the terminal portion of the plasma curve terminal half-life (t½) for 50mg [14C]-SHP626 and RAD
時間枠:Day 1 to Day 10
Day 1 to Day 10
Total body clearance (CL/F ) of 50mg [14C]-SHP626 and RAD for extravascular administration divided by the fraction of dose absorbed
時間枠:Day 1-10
Day 1-10
Volume of distribution (Vz/F ) of 50mg [14C]-SHP626 and RAD associated with the terminal slope following extra-vascular administration divided by the fraction of dose absorbed
時間枠:Day 1-10
Day 1-10
Cumulative amount (Aef )of RAD recovered in stool over the dosing interval
時間枠:Day 1-10
Day 1-10
Excreted Percent of RAD recovered in stool over the dosing interval
時間枠:Day 1-10
Day 1-10
Cumulative amount (Aeu ) of RAD recovered in urine over the dosing interval
時間枠:Day 1-10
Day 1-10
Excreted Percent of RAD recovered in urine over the dosing interval
時間枠:Day 1-10
Day 1-10
Renal Clearance (CLR ) of 50mg [14C]-SHP626
時間枠:Day 1 -10
Day 1 -10

二次結果の測定

結果測定
メジャーの説明
時間枠
Characterize and identify metabolites of [14C]-SHP626 in plasma by accelerator mass spectrometry for radioactivity quantification
時間枠:Day 1 to day 10
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
Day 1 to day 10
Characterize and identify metabolites of [14C]-SHP626 in urine by accelerator mass spectrometry for radioactivity quantification
時間枠:Day 1 to day 10
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
Day 1 to day 10
Characterize and identify metabolites of [14C]-SHP626 in feces by liquid scintillation counting
時間枠:Day 1 to day 10
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
Day 1 to day 10
Assess the safety and tolerability of [14C]-SHP626 by adverse events (AEs) defined as changes, including changes from baseline in physical examination findings
時間枠:Screening to day 7
AEs will be coded using the agreed upon version of MedDRA. The number of events, incidence, and percentage of TEAEs will be calculated overall, by system organ class and by preferred term. TEAEs will be further summarized by severity and relationship to investigational product. AEs related to investigational product, AEs leading to withdrawal, SAEs, and deaths will be similarly summarized/listed.
Screening to day 7
Changes from baseline in vital signs
時間枠:Screening to day 7
Screening to day 7
Changes from baseline in ECGs
時間枠:Screening to day 7
Screening to day 7
Changes from baseline in hematology
時間枠:Screening to day 7
Screening to day 7
Changes from baseline in coagulation
時間枠:Screening to day 7
Screening to day 7
Changes in baseline in urinalysis
時間枠:Screening to day 7
Screening to day 7
Changes in baseline in chemistry
時間枠:Screening to day 7
Screening to day 7

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

捜査官

  • 主任研究者:Nicholas Siebers, MD、Covance Clinical Pharmacology

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

2015年10月1日

一次修了 (実際)

2015年10月1日

研究の完了 (実際)

2015年10月1日

試験登録日

最初に提出

2015年9月30日

QC基準を満たした最初の提出物

2015年10月6日

最初の投稿 (見積もり)

2015年10月8日

学習記録の更新

投稿された最後の更新 (実際)

2019年5月1日

QC基準を満たした最後の更新が送信されました

2019年4月30日

最終確認日

2019年4月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • SHP626-102

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。

非アルコール性脂肪性肝炎の臨床試験

SHP626の臨床試験

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