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A Study Comparing Once-Daily vs. Twice-Daily Dosing of X4P-001 in Healthy Volunteers

2018年12月5日 更新者：X4 Pharmaceuticals

A Phase 1 Study Comparing Once-Daily vs. Twice-Daily Dosing of X4P-001 in Healthy Volunteers

This study will evaluate the safety, tolerability and pharmacokinetics of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily.

This study will also assess the pharmacodynamic effects of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily on levels of circulating white blood cells (total and by cell type).

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

This study will be conducted in 15 healthy volunteers at a clinical research unit located in Daytona Beach, Florida. Screening will be done within 35 days prior to the first dose of study drug (first Dosing Period). Each subject will complete two 10-day Dosing Periods, one using once daily dosing and the other twice daily dosing. The interval between the Dosing Periods will be 7 to 17 days. Patients will be randomly assigned to which regimen is administered the first Dosing Period. Safety laboratory tests will be performed at screening, and prior to and after each Dosing Period. End-of-Study (EOS) visit, the final study event, will be performed 14 to 21 days after the last dose of study drug.

研究の種類

介入

入学 (実際)

15

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

  • アメリカ
    • Florida
      • Daytona Beach、Florida、アメリカ、32117
        • Covance Cru, Inc.

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～65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Between 18 and 65 years of age, inclusive.
  2. Have signed the current approved informed consent form.
  3. For women of childbearing potential, (a) agree to use effective contraceptive methods from screening, through the study, and for at least 4 weeks after the last dose of study drug; and (b) have a negative pregnancy test (serum or urine) at screening and on Day -1 prior to each Dosing period.
  4. For men, agree both to (a) use effective contraceptive methods and (b) abstain from donating sperm, from admission to the in-residence unit prior to the first Dosing Period, through the study, and for at least 4 weeks after the last dose of study drug.
  5. Be willing and able to comply with this protocol.

Exclusion Criteria:

  1. Is an employee of the Phase 1 unit or an immediate family member of an employee.
  2. Has a BMI <18.0 or >30.0.
  3. Has a history of hypersensitivity or allergy to any drug compound, food or other substance assessed as significant by the Investigator.
  4. Has a history or presence of any medical condition capable of altering absorption, metabolism or elimination of drugs (history of routine cholecystectomy is permitted).
  5. Has alcohol intake exceeding 21 units per week for males or 14 units per week for females, where 1 unit = 12 oz (360 mL) beer, 5 oz (150 mL) wine, or 1.5 oz (45 mL) distilled spirits.
  6. Has within the past 12 months used illicit drugs.
  7. Has within the past 6 months been a smoker or used tobacco or nicotine replacement products.
  8. Is within 6 months post-partum or termination of a pregnancy.
  9. Has within the past 30 days or 5 half-lives, whichever is longer, participated in any other clinical trial involving an investigational treatment.
  10. Has within the past 30 days had an acute medical illness, including an active infection.
  11. Has within the past 30 days donated more than 500 mL of blood.
  12. Has within the past 30 days, or is scheduled to have while participating in the study, surgery requiring general anesthesia.
  13. Has within the past 30 days, or is scheduled to have while participating in the study, any immunizations.
  14. Has within the past 14 days been nursing.
  15. Has within the past 14 days donated plasma.
  16. Has within the past 14 days used any prescription or over the counter medications, unless deemed acceptable by the Investigator.
  17. Has positive urine or serum test for drugs of abuse or for cotinine.

  18. Has positive serologic laboratory tests:

    • Human immunodeficiency virus (HIV-1 or -2)
    • Hepatitis C virus (HCV)
    • Hepatitis B virus (HBV)
  19. Has confirmed abnormal safety laboratory tests representing CTCAE Grade 2 or higher. Subjects with Grade 1 abnormalities may be enrolled with the approval of the Investigator and the Sponsor.
  20. Has insufficient venous access to permit the scheduled blood sampling.
  21. Has any other medical or personal condition or finding that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the subject, or may preclude the subject's successful completion of the clinical trial.

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：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
実験的：X4P-001 QD
Subjects will receive study drug in two dosing periods. In this arm subjects will receive drug once daily in the first period, followed by twice daily in the second dosing period.
薬：X4P-001
100 mg capsules, administered orally for 10 days either as 200 mg BID or 400 mg QD. Subjects will be randomized to determine if they will receive the drug QD or BID in the first dosing period.
他の名前：
  • AMD11070
実験的：X4P-001 BID
Subjects will receive study drug in two dosing periods. In this arm subjects will receive drug twice daily in the first period, followed by once daily in the second dosing period.
薬：X4P-001
100 mg capsules, administered orally for 10 days either as 200 mg BID or 400 mg QD. Subjects will be randomized to determine if they will receive the drug QD or BID in the first dosing period.
他の名前：
  • AMD11070

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
Incidence of treatment emergent adverse events (safety and tolerability) in subjects administered X4P-001 200 mg twice daily compared with 400 mg once daily.
時間枠：Up to 14 to 21 days post-last dose
Safety assessments include ongoing monitoring of adverse events, ongoing monitoring of concomitant medications and regulatory scheduled vital signs, physical examinations and laboratory tests (hematology, clinical chemistry, urinalysis and coagulation).
Up to 14 to 21 days post-last dose
Maximum Plasma Concentration (Cmax) of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily.
時間枠：Up to 48 hours post-dose
Cmax data will be collected to determine the pharmacokinetics of X4P-001 administered as 200 mg twice daily and 400 mg once daily.
Up to 48 hours post-dose
Area under the curve (AUC) of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily.
時間枠：Up to 48 hours post-dose
AUC data will be collected to determine the pharmacokinetics of X4P-001 administered as 200 mg twice daily and 400 mg once daily.
Up to 48 hours post-dose
Minimum Plasma Concentration (Cmin) of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily.
時間枠：Up to 48 hours post-dose
Amin data will be collected to determine the pharmacokinetics of X4P-001 administered as 200 mg twice daily and 400 mg once daily.
Up to 48 hours post-dose

二次結果の測定

結果測定
メジャーの説明
時間枠
To assess the pharmacodynamic effects of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily on levels of circulating white blood cells (total and by cell type).
時間枠：Up to 48 hours post-dose
Whole blood samples will be obtained for PD studies concurrently with the PK samples. PD will be assessed via complete blood counts (CBC) with differential.
Up to 48 hours post-dose
To assess the pharmacodynamic effects of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily on levels of circulating mononuclear cell phenotypes by cell surface markers.
時間枠：Up to 48 hours post-dose
Whole blood samples will be obtained for PD studies concurrently with the PK samples. PD will be assessed via complete blood counts (CBC) with differential.
Up to 48 hours post-dose

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

X4 Pharmaceuticals

協力者

Covance

捜査官

  • スタディディレクター：Lu Gan, MD, PhD、X4 Pharmaceuticals, Inc.

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 (実際)

2016年1月12日

一次修了 (実際)

2016年2月28日

研究の完了 (実際)

2016年2月28日

試験登録日

最初に提出

2016年2月4日

QC基準を満たした最初の提出物

2016年2月8日

最初の投稿 (見積もり)

2016年2月12日

学習記録の更新

投稿された最後の更新 (実際)

2018年12月7日

QC基準を満たした最後の更新が送信されました

2018年12月5日

最終確認日

2018年12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

  • X4P-001-REGA

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?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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。

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