A Study to Learn How Different Forms of the Study Medicine Called PF-08049820 Are Absorbed and Eliminated in Healthy Adults
A PHASE 1, OPEN-LABEL, RANDOMIZED, 5-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF ONE IMMEDIATE RELEASE AND TWO MODIFIED-RELEASE FORMULATIONS OF PF-08049820 ADMINISTERED ORALLY UNDER FASTED AND FED CONDITIONS (PART A), AND A FIXED SEQUENCE STUDY TO ASSESS THE EFFECT OF RABEPRAZOLE ON THE PHARMACOKINETICS OF PF-08049820 (PART B), IN HEALTHY ADULTS
The purpose of this study is to learn how different forms of the study medicine called PF-08049820 are absorbed and eliminated in healthy adults. The study will assess whether the study medicine is absorbed differently when taken with or without food. It will also assess absorption when the study medicine is taken with another medicine called rabeprazole. Rabeprazole is an FDA approved medicine that reduces stomach acid.
The study has two parts. In Part A, participants will take three forms of study medicine, one after the other. They will take each form either with or without food for a total of five doses. Each dose will be separated by a few days. Participants will stay in the clinic for about two weeks. They will receive a telephone follow-up call about a month after the last dose.
In Part B, participants will take three forms of study medicine. They will take each one with or without food, and with or without another medicine called rabeprazole. This means they will take a total of six doses of study medicine. Each dose will be separated by a few days. Participants will stay at the clinic for about three weeks, and about a month after their last dose. They will get a follow-up phone call. Part B may or may not be conducted depending on the results from Part A.
The study is seeking participants who:
- Are males or females,
- Are at least 18 years of age,
- Have a body mass index (BMI) 16 to 32 kilograms per meter squared (kg/m2). Have a total body weight of more than 50 kilograms (kg) (110 pounds).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 1단계
연락처 및 위치
연구 장소
-
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Connecticut
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New Haven, Connecticut, 미국, 06511
- Pfizer Clinical Research Unit - New Haven
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy males and females.
- At least 18 years of age
- Body mass index (BMI) of 16-32 kg/m2; and a total body weight >50kg (110 lb.).
Exclusion Criteria:
- Evidence or history of clinically significant medical conditions.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B or hepatitis C.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Sequence 5 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
Administered orally |
|
실험적: Sequence 7 (Optional Part B)
3 different formulations of PF-08049820 administered orally with or without rabeprazole under fasted or fed conditions. |
Administered orally Administered orally |
|
실험적: Sequence 1 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
Administered orally |
|
실험적: Sequence 2 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
Administered orally |
|
실험적: Sequence 3 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
Administered orally |
|
실험적: Sequence 4 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
Administered orally |
|
실험적: Sequence 6 (Part A)
3 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
Administered orally |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
기간: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
Part A: Evaluate the relative bioavailability of different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820. |
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
|
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
기간: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820. |
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
|
Maximum observed plasma concentration (Cmax)
기간: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820. |
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
기간: Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
|
Part A and optional Part B |
Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
|
|
Number of Participants With Serious Adverse Events (SAEs)
기간: Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
|
Part A and optional Part B |
Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
|
|
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
기간: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
Part A and optional Part B |
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
기간: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
Part A and optional Part B |
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
기간: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
Part A and optional Part B |
Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
|
|
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
기간: Baseline up to Day 16 for Part A
|
Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820. |
Baseline up to Day 16 for Part A
|
|
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
기간: Baseline up to Day 16 for Part A
|
Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820. |
Baseline up to Day 16 for Part A
|
|
Maximum observed plasma concentration (Cmax)
기간: Baseline up to Day 16 for Part A
|
Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820. |
Baseline up to Day 16 for Part A
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Pfizer CT.gov Call Center, Pfizer
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- C6231008
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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