- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02680782
A Study Comparing Once-Daily vs. Twice-Daily Dosing of X4P-001 in Healthy Volunteers
2018년 12월 5일 업데이트: 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).
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
15
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Florida
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Daytona Beach, Florida, 미국, 32117
- Covance Cru, Inc.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Between 18 and 65 years of age, inclusive.
- Have signed the current approved informed consent form.
- 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.
- 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.
- Be willing and able to comply with this protocol.
Exclusion Criteria:
- Is an employee of the Phase 1 unit or an immediate family member of an employee.
- Has a BMI <18.0 or >30.0.
- Has a history of hypersensitivity or allergy to any drug compound, food or other substance assessed as significant by the Investigator.
- Has a history or presence of any medical condition capable of altering absorption, metabolism or elimination of drugs (history of routine cholecystectomy is permitted).
- 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.
- Has within the past 12 months used illicit drugs.
- Has within the past 6 months been a smoker or used tobacco or nicotine replacement products.
- Is within 6 months post-partum or termination of a pregnancy.
- Has within the past 30 days or 5 half-lives, whichever is longer, participated in any other clinical trial involving an investigational treatment.
- Has within the past 30 days had an acute medical illness, including an active infection.
- Has within the past 30 days donated more than 500 mL of blood.
- Has within the past 30 days, or is scheduled to have while participating in the study, surgery requiring general anesthesia.
- Has within the past 30 days, or is scheduled to have while participating in the study, any immunizations.
- Has within the past 14 days been nursing.
- Has within the past 14 days donated plasma.
- Has within the past 14 days used any prescription or over the counter medications, unless deemed acceptable by the Investigator.
- Has positive urine or serum test for drugs of abuse or for cotinine.
Has positive serologic laboratory tests:
- Human immunodeficiency virus (HIV-1 or -2)
- Hepatitis C virus (HCV)
- Hepatitis B virus (HBV)
- 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.
- Has insufficient venous access to permit the scheduled blood sampling.
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
다른 이름들:
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실험적: 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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Incidence of treatment emergent adverse events (safety and tolerability) in subjects administered X4P-001 200 mg twice daily compared with 400 mg once daily.
기간: Up to 14 to 21 days post-last dose
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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).
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Up to 14 to 21 days post-last dose
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Maximum Plasma Concentration (Cmax) of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily.
기간: Up to 48 hours post-dose
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Cmax data will be collected to determine the pharmacokinetics of X4P-001 administered as 200 mg twice daily and 400 mg once daily.
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Up to 48 hours post-dose
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Area under the curve (AUC) of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily.
기간: Up to 48 hours post-dose
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AUC data will be collected to determine the pharmacokinetics of X4P-001 administered as 200 mg twice daily and 400 mg once daily.
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Up to 48 hours post-dose
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Minimum Plasma Concentration (Cmin) of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily.
기간: Up to 48 hours post-dose
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Amin data will be collected to determine the pharmacokinetics of X4P-001 administered as 200 mg twice daily and 400 mg once daily.
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Up to 48 hours post-dose
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
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).
기간: Up to 48 hours post-dose
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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.
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Up to 48 hours post-dose
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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.
기간: Up to 48 hours post-dose
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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.
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Up to 48 hours post-dose
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 1월 12일
기본 완료 (실제)
2016년 2월 28일
연구 완료 (실제)
2016년 2월 28일
연구 등록 날짜
최초 제출
2016년 2월 4일
QC 기준을 충족하는 최초 제출
2016년 2월 8일
처음 게시됨 (추정)
2016년 2월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 12월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 12월 5일
마지막으로 확인됨
2018년 12월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- X4P-001-REGA
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
X4P-001에 대한 임상 시험
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X4 Pharmaceuticals완전한발덴스트롬 마크로글로불린혈증미국, 그리스
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X4 Pharmaceuticals모집하지 않고 적극적으로
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X4 Pharmaceuticals아직 모집하지 않음
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X4 Pharmaceuticals완전한
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X4 Pharmaceuticals모집하지 않고 적극적으로WHIM 증후군미국, 덴마크, 호주, 오스트리아, 프랑스, 헝가리, 이스라엘, 이탈리아, 대한민국, 네덜란드, 러시아 연방, 스페인, 칠면조