이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

GW824575 First Time in Human

2017년 10월 17일 업데이트: GlaxoSmithKline

A Single-centre, Masked, Placebo-controlled Four Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of the CC-chemokine Receptor 3 (CCR3) Antagonist, GW824575, Coadministered With or Without Food in Healthy Male Subjects

This study is the first administration of GW824575 in humans. This will be a single centre, masked, placebo-controlled study, to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GW824575, given as single and repeated oral doses to healthy male subjects. The study will be comprised of 4 parts and enroll approximately 40 subjects: Part A will consist of two cohorts of 8 healthy male subjects to assess the safety, tolerability, PK, and PD of ascending single oral doses of GW824575. All available safety, tolerability, and PK data will be monitored prior to each dose escalation. In order to support the possible indication for age-related macular degeneration (AMD), Part B will be one cohort of 12 subjects to examine the safety, tolerability, PK, and PD of a repeated dose of GW824575 over 21 days in healthy male subjects who are greater than or equal to 50 years of age. The total daily dose in this cohort will not exceed the maximum tolerated dose (MTD) from Parts A and D. Subjects in this cohort will undergo ophthalmology assessments before receiving investigational product and after Day 7 of the 21-day in-patient treatment, after steady state has been reached. As part of protocol amendment 2, Part C (Cohort 4) is removed from the protocol. Part D, added under protocol amendment 2, will consist of one cohort of 12 healthy male subjects to assess safety, tolerability, PK, and PD of ascending single doses of GW824575 as well as the effect of food on the PK of GW824575.

연구 개요

상세 설명

Part A will consist of two cohorts of healthy male subjects to assess the safety, tolerability, and PK of ascending single oral doses of GW824575. The sponsor will review available safety, tolerability, and PK data and, where available, PD receptor occupancy (from the eosinophil shape change data) data before each dose escalation. Outcome measures in Part A will be assessed and presented through 48 hours post-dose for each of up to 4 single dose escalations per cohort. Part B will be one cohort to examine the safety, tolerability and PK of a repeated dose of GW824575 over 21 days in healthy male subjects who are greater than or equal to 50 years of age. Subjects in this cohort will undergo ophthalmic assessments before receiving investigational product and after Day 7 of the 21-day in-patient treatment, after steady state has been reached. The PD endpoints such as receptor occupancy will be assessed. The dosing regimen (once or twice daily) will be determined by PK data from Part A; however, regardless of dosing regimen, subjects will only receive a single dose in the morning on Days 1 and 21 of the treatment period. Outcome measures in Part B (Cohort 3) will be assessed and presented through 21 days repeat dosing until 48 hours post-dose last dose (i.e., on Day 23). If a safety signal is noted during, or after, the conduct of Cohort 3 of the study; the cohort may be halted or dose down-titrated, and an additional cohort, at a lower dose, may be instituted in Part B as Cohort 5. Dose selection for the additional cohort (Cohort 5) will be informed by the aggregate safety, PK, and PD data available at that time. Part D will consist of one cohort of healthy male subjects. The cohort will 1) explore the effect of a high fat meal on the PK of GW824575 during two treatment periods with approximately 48 hour washout between periods and 2) assess the safety, tolerability, and PK of ascending single oral doses of GW824575 administered in the fasting state or with a standard meal in up to 3 additional treatment periods with at least 6-day washout between periods. The sponsor will review available safety, tolerability, and PK data and, where available, PD RO (from the eosinophil shape change data) data before each dose escalation.

연구 유형

중재적

등록 (실제)

16

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • London, 영국, NW10 7EW
        • GSK Investigational Site

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

남성

설명

Inclusion Criteria:

  • AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • For subjects in Parts A or D - Male subjects between 18 and 65 years of age inclusive, at the time of signing the informed consent.

For subjects in Part B - Male subjects greater than or equal to 50 years of age, at the time of signing the informed consent..

  • Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in protocol. This criterion must be followed from the time of the first dose of study medication until 4 months post-last dose.
  • Body weight greater than or equal to 55 kg and BMI within the range 18 - 31 kg/m2 (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Average QTc < 450 msec.
  • Normotensive, after having rested quietly in a supine position for at least 15 minutes, with a systolic blood pressure less than or equal to 120 mmHg and diastolic blood pressure less than or equal to 80mmHg and a heart rate less than or equal to 100 beats per minute. Subjects with "pre-hypertension" (systolic blood pressure 121-140 mmHg and diastolic blood pressure 81 to 99mmHg) must be cleared by the medical monitor.
  • Willingness and ability to swallow multiple size 00 capsules as part of study participation.
  • For subjects in Part B only - Best-corrected visual acuity better than 20/80 (Snellen equivalent; 54 or more ETDRS letters) in both eyes.

Exclusion Criteria:

  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A positive pre-study drug/alcohol screen.
  • A positive test for HIV antibody.
  • Significant infection within 4 weeks prior to the first dosing day.
  • History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units for males. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months (12 weeks), 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Unable to refrain from prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication and throughout the study, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day period.
  • Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
  • Any prior intraocular surgery, excluding cataract surgery.
  • Any prior eye surgery within three months to first dose of study medication.
  • Subjects with glaucoma (controlled or uncontrolled).
  • Inability to withhold contact lens wear from the time of the screening ophthalmic assessments until the treatment ophthalmic assessments have been performed (the wearing of glasses is permitted).
  • Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoxamine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, and ethambutol).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 특수 증상
  • 할당: 무작위
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: GW824575
Investigational treatment - Swedish Orange Coloured, opaque hard gelatin capsule
Placebo
위약 비교기: GW824575 matched-placebo
Placebo
Investigational treatment - Swedish Orange Coloured, opaque hard gelatin capsule

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Subject tolerability as measured by the number (and frequency) of subjects who experience adverse events after single ascending doses of GW824575
기간: Parts A and D - Through the expected 48-hour duration of hospital stay.Through the expected 48-hour duration of hospital stay.
To assess the safety and tolerability of single doses of GW824575 in healthy male subjects.
Parts A and D - Through the expected 48-hour duration of hospital stay.Through the expected 48-hour duration of hospital stay.
Subject tolerability as measured by the number (and frequency) of subjects who experience adverse events after repeat doses of GW824575
기간: Part B through the expected 23-day duration of hospital stay.
To assess the safety and tolerability of repeat doses of GW824575 in healthy male subjects who are greater than or equal to 50 years of age
Part B through the expected 23-day duration of hospital stay.

2차 결과 측정

결과 측정
측정값 설명
기간
Pharmacokinetic parameters such as Cmax, AUC, half-life, Tmax of GW824575 after single dosing.
기간: Parts A and D - predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours of each hospital stay.
To characterise the PK profile of single doses of GW824575 in healthy male subjects
Parts A and D - predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours of each hospital stay.
Pharmacokinetic parameters such as Cmax, AUC, half-life, Tmax of GW824575 after repeat dosing.
기간: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24, hours on Day 1 of dosing and on Day 21 of dosing in Part B.
To characterise the PK profile of repeat doses of GW824575 in healthy male subjects who are greater than or equal to 50 years of age
predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24, hours on Day 1 of dosing and on Day 21 of dosing in Part B.
Single dose - eosinophil shape change assay
기간: 24 to 27 hours post dose.
To determine the PD effect of single doses of GW824575 in healthy male subjects.
24 to 27 hours post dose.
Repeat dose - eosinophil shape change assay
기간: Part B at 3, 8 and 24 hours post last dose on Day 21.
To determine the PD effect of repeat doses of GW824575 in healthy male subjects who are greater than 50 years of age
Part B at 3, 8 and 24 hours post last dose on Day 21.
Urine, serum and bile sampling for GW824575
기간: Part B (only) at 12-hours after 12 days of repeat dosing.
To investigate the metabolism of GW824575 following single and repeat doses in healthy male subjects who are greater than or equal to 50 years of age.
Part B (only) at 12-hours after 12 days of repeat dosing.
Changes in safety laboratory values after single ascending doses of GW824575
기간: Parts A and D - At the conclusion of the expected 48-hour duration of hospital stay.
To assess the safety of single dose of GW824575 in healthy male subjects
Parts A and D - At the conclusion of the expected 48-hour duration of hospital stay.
Changes in safety laboratory values after repeat dosing with GW824575
기간: Part B through the expected 22-day duration of hospital stay.
To assess the safety of repeat doses of GW824575 in healthy male subjects who are greater than or equal to 50 years of age
Part B through the expected 22-day duration of hospital stay.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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)

2012년 2월 1일

기본 완료 (실제)

2012년 4월 12일

연구 완료 (실제)

2012년 4월 12일

연구 등록 날짜

최초 제출

2012년 2월 9일

QC 기준을 충족하는 최초 제출

2012년 3월 8일

처음 게시됨 (추정)

2012년 3월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 10월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 10월 17일

마지막으로 확인됨

2017년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 115802

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

연구 데이터/문서

  1. 임상 연구 보고서
    정보 식별자: 115802
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  2. 통계 분석 계획
    정보 식별자: 115802
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  3. 연구 프로토콜
    정보 식별자: 115802
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  4. 정보에 입각한 동의서
    정보 식별자: 115802
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  5. 데이터 세트 사양
    정보 식별자: 115802
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  6. 개별 참가자 데이터 세트
    정보 식별자: 115802
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
  7. 주석이 달린 사례 보고서 양식
    정보 식별자: 115802
    정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

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. .

망막 질환에 대한 임상 시험

GW824575 matched-placebo에 대한 임상 시험

구독하다