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임상시험 NCT05377255은(는) 오피오이드 과다 복용에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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이머전트 바이오솔루션스Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults 1상 24 무작위 배정 오픈 라벨
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT05377255은(는) 치료을(를) 알아보기 위한 연구였습니다. 이 연구는 오피오이드 과다 복용에 대한 것이었으며, 완료 된 1상 중재연구이었습니다. 연구는 2022년 3월 28일에 시작되어 24명의 참여자와 함께 진행되었습니다. 이머전트 바이오솔루션스이(가) 진행한 이 연구는 2022년 5월 10일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 3월 18일에 갱신되었습니다.
간단한 개요
This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.
상세한 설명
Based on the intended AP003 product presentation there will be two devices in each carton allowing for administration of a total of 16 mg. This study is designed for subjects to receive naloxone therapy either through the AP003 device or through the currently approved NARCAN® nasal spray (4 mg) device (per label), reference therapy. After administration of the therapy patients will be followed by a 48-hour washout pe...더 보기
공식 제목
A Phase 1, Open Label, Randomized Study to Investigate the Pharmacokinetics and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adult Participants
질환명
오피오이드 과다 복용기타 연구 식별자
- EBS-NAR-001
NCT 번호
실제 연구 시작일
2022-03-28
최신 업데이트 게시
2024-03-18
예상 연구 완료일
2022-05-10
계획된 등록 인원
24
연구종류
중재연구
단계/상
1상
상태
완료
키워드
NARCAN
Opioid Overdose
Naloxone
Intranasal
Opioid Overdose
Naloxone
Intranasal
주요 목적
치료
설계 할당
무작위배정
중재 모델
교차 설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
기타Arm 1 Interventional Therapy Subjects will first receive 4 doses of 4 mg each (total: 16 mg) of naloxone through the AP003 device (Arm 1) before the washout period. | 16 mg naloxone AP003 4 doses of 4 mg each (total: 16 mg) of naloxone through the AP003 device 8 mg naloxone NARCAN Nasal Spray 2 doses of 4 mg each (total: 8 mg) of the naloxone through the NARCAN Nasal Spray device |
기타Arm 2 Reference Therapy Subjects will first receive 2 doses of 4 mg each (total: 8 mg) of the naloxone through the NARCAN Nasal Spray device (reference therapy, Arm 2) before the washout period. | 16 mg naloxone AP003 4 doses of 4 mg each (total: 16 mg) of naloxone through the AP003 device 8 mg naloxone NARCAN Nasal Spray 2 doses of 4 mg each (total: 8 mg) of the naloxone through the NARCAN Nasal Spray device |
주요결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Mean naloxone plasma concentration AP003 dosing periods. | The mean naloxone plasma concentration during the two AP003 dosing periods. | PK samples taken at various timepoints over the course of Pre-dose and post-dose for 12 hours. |
Mean naloxone plasma concentration Narcan dosing periods | The mean naloxone plasma concentration during the two Narcan dosing periods. | PK samples taken at various timepoints over the course of Pre-dose and post-dose for 12 hours. |
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAE) | Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAE) by treatment thru End of Study Visit (within 7 days after 2nd dose). | Through end of study visit (within 7 days after second dose) |
Incidence of abnormal vital signs | Incidence of abnormal vital signs (heart rate, blood pressure, and respiration rate) by treatment thru End of Study Visit (within 7 days after 2nd dose). | Through end of study visit (within 7 days after second dose) |
Incidence of clinically significant ECG | Incidence of clinically significant ECG by treatment thru End of Study Visit (within 7 days after 2nd dose). | Through end of study visit (within 7 days after second dose) |
Incidence of clinical laboratory changes | Incidence of clinical laboratory changes by treatment thru End of Study Visit (within 7 days after 2nd dose). | Through end of study visit (within 7 days after second dose) |
Incidence of adverse events of special interest (AESI) indicating of nasal irritation | Incidence of adverse events of special interest (AESI) indicating of nasal irritation (erythema, edema, and erosion) by treatment thru End of Study Visit (within 7 days after 2nd dose). | Through end of study visit (within 7 days after second dose) |
Incidence of changes in B-SIT assessment | Incidence of changes in B-SIT assessment within an AP003 period thru End of Study Visit (within 7 days after 2nd dose). | Through end of study visit (within 7 days after second dose) |
적격성 기준
연령대
성인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
Are able to consent and freely provide informed consent.
Females and males 18-55 years of age, inclusive.
Have a body mass index (BMI) less than or equal to 34.0 kg/m2.
Generally healthy, in the opinion of the Investigator, based on medical history, physical examination, vital signs, screening laboratory assessments and 12-lead ECG evaluation.
If female:
Have a negative pregnancy test at Screening (serum pregnancy test) and before dosing at Day -1 (urine pregnancy test)
Female subjects of non-childbearing potential must be:
- Post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented FSH levels ≥40 mIU/mL; or
- Surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or tubal ligation) at least 3 months prior to dosing.
Women of childbearing potential who are not planning to be pregnant during the study period and who are using one of the following effective methods of contraception during the study period and for at least 30 days after last study visit:
- Simultaneous use of hormonal contraceptive (e.g. oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device for at least 4 weeks prior to dosing (must agree to use the same contraceptive throughout the study) and condom for the male partner.
- Simultaneous use of diaphragm or cervical cap with spermicide and condom for the male partner, started at least 21 days prior to dosing.
- Subjects planning to become pregnant during the study or currently breastfeeding.
- Any acute condition, in the opinion of the Investigator, that is not fully resolved at least 4 weeks prior to baseline.
- Subject has a deviated septum, previous rhinoplasty, abnormal nasal anatomy, other nasal symptoms (i.e., blocked and/or runny nose), or other nasal surgeries (i.e., polyp removal) within 1 year, or needs to use another nasal spray product during study.
- Subject with current upper respiratory infection (URI) or has had URI within 7 days prior to screening.
- Subject has had an episode of epistaxis within 30 days prior screening or has experienced recurrent episodes of epistaxis within 1 year prior to screening.
- Subject has used any prescription or nonprescription drugs/supplements with increased risk of bleeding within 28 days or 5 half-lives (whichever is longer) or complementary and alternative medicines within 28 days before the first dose of study drug with exception of oral contraceptives. All other prescription medications, over-the-counter, and natural health products within 14 days or 5 half-lives prior to the first dosing.
- Subject is currently participating in another clinical study of an investigational drug or has been dosed with any investigational drug within 30 days or 5 half-lives (whichever is longer) of the compound.
이머전트 바이오솔루션스연락처 정보가 없습니다.
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Florida
Syneos Health Clinical Research Services, Miami, Florida, 33136, United States