A Study to Evaluate the Safety and Pharmacokinetics of Multiple Doses Upadacitinib, Tofacitinib, and Baricitinib in Healthy Adult Volunteers
A Phase 1 Open-label, Multiple Dose Study of Upadacitinib, Tofacitinib, and Baricitinib in Healthy Subjects to Evaluate Pharmacodynamic Biomarkers
This is a Phase 1, open label, five arm study to evaluate the pharmacodynamic effects of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adult participants.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: ABBVIE CALL CENTER
- 전화번호: 844-663-3742
- 이메일: abbvieclinicaltrials@abbvie.com
연구 장소
-
-
Illinois
-
Grayslake, Illinois, 미국, 60030
- 모병
- Acpru /Id# 286751
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, Physical Exam (PE), vital signs, laboratory profile and a 12-lead Electrocardiogram (ECG).
- A female must not be pregnant, or breastfeeding and is not considering becoming pregnant, cryopreserving her eggs or donating eggs during the study or for approximately 30 days after the last dose of study treatment.
Exclusion Criteria:
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, two or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster, one or more prior episodes of disseminated herpes simplex (including eczema herpeticum) or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
- History or evidence of active tuberculosis (TB) disease or latent TB infection.
- Participant has prior exposure to upadacitinib, tofacitinib or baricitinib within the past 90 days.
- Participant requires any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis.
- Participant has used any medications, vitamins and/or herbal supplements within the 2-week period prior to study treatment administration.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Arm 1: Multiple doses of Upadacitinib
Upadacitinib will be administered once daily |
Oral Tablet |
|
실험적: Arm 2: Multiple doses of Tofacitinib
Tofacitinib will be administered twice daily |
Oral Tablet |
|
실험적: Arm 3: Multiple doses of Upadacitinib
Upadacitinib will be administered once daily |
Oral Tablet |
|
실험적: Arm 4: Multiple doses of Tofacitinib
Tofacitinib will be administered twice daily |
Oral Tablet |
|
실험적: Arm 5: Multiple doses of Baricitinib
Baricitinib will be administered once daily |
Oral Tablet |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE)
기간: Up to 44 Days
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. |
Up to 44 Days
|
|
Average plasma concentration (Cavg) of Upadacitinib
기간: Up to 44 Days
|
Cavg of Upadacitinib |
Up to 44 Days
|
|
Average plasma concentration (Cavg) of Tofacitinib
기간: Up to 44 Days
|
Cavg of Tofacitinib |
Up to 44 Days
|
|
Average plasma concentration (Cavg) of Baricitinib
기간: Up to 44 Days
|
Cavg of Baricitinib |
Up to 44 Days
|
|
Area under the concentration-time curve over 24 hours (AUC24) of Upadacitinib
기간: Up to 44 Days
|
AUC24 of Upadacitinib |
Up to 44 Days
|
|
Area under the concentration-time curve over 24 hours (AUC24) of Tofacitinib
기간: Up to 44 Days
|
AUC24 of Tofacitinib |
Up to 44 Days
|
|
Area under the concentration-time curve over 24 hours (AUC24) of Baricitinib
기간: Up to 44 Days
|
AUC24 of Baricitinib |
Up to 44 Days
|
|
Maximum Observed Plasma Concentration (Cmax) of Upadacitinib
기간: Up to 44 Days
|
Cmax of Upadacitinib |
Up to 44 Days
|
|
Maximum Observed Plasma Concentration (Cmax) of Tofacitinib
기간: Up to 44 Days
|
Cmax of Tofacitinib |
Up to 44 Days
|
|
Maximum Observed Plasma Concentration (Cmax) of Baricitinib
기간: Up to 44 Days
|
Cmax of Baricitinib |
Up to 44 Days
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: ABBVIE INC., AbbVie
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- M26-625
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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