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A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants

2026년 9월 15일 업데이트: AstraZeneca

A Phase I, Randomized, Single-dose, Crossover, 2-Period, Open-Label Study to Assess the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants

The purpose of this study is to measure the pharmacokinetics (PK-how the body processes the study drug) of elecoglipron in healthy participants when taken by mouth as different formulations.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This is a phase I, open-label, randomized, 2-period crossover study with 4-cohorts. All 4 cohorts are independent and non-sequential parts in this study. Each cohort will evaluate 2 formulations (test formulation and reference formulation) of elecoglipron across 2 study treatment periods. Participants within each cohort will be randomized to one of 2 treatment sequences (Test-Reference or Reference-Test).

In total 3 formulations will be evaluated at 2 dose levels each:

  • Reference formulation
  • Test formulation 1
  • Test formulation 2

The study will comprise:

  • A Screening Period.
  • 2 treatment periods in each cohort - Period 1, and Period 2 during which participants will be admitted to the Clinical Unit and receive a single oral dose of elecoglipron in each period.
  • A final Follow-up Visit.

연구 유형

중재적

등록 (추정된)

152

단계

  • 1단계

연락처 및 위치

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

연구 연락처

연구 장소

  • 미국
    • California
      • Glendale, California, 미국, 91206
        • 모병
        • Research Site
    • Maryland
      • Brooklyn, Maryland, 미국, 21225
        • 모병
        • Research 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

  • 성인

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

  • Healthy participants with suitable veins for cannulation or repeated venipuncture.
  • All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
  • Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.
  • Females of non-childbearing potential must be confirmed at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.
  • Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods.
  • Have a body mass index between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg.

Exclusion Criteria:

  • History of any clinically important disease or disorder.
  • History of acute pancreatitis.
  • History or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
  • Any clinically important illness, medical/surgical procedure, or trauma.
  • Participants who have previously received elecoglipron within the last 3 months.

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: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Cohort 1-Treatment Sequence A
Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose A) in Period 2.
의약품: Elecoglipron Reference Formulation Dose A
Elecoglipron tablets will be administered orally.
의약품: Elecoglipron Test formulation 1 Dose A
Elecoglipron tablets will be administered orally.
실험적: Cohort 1 - Treatment Sequence B
Participant will receive a single dose of elecoglipron test formulation 1 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2.
의약품: Elecoglipron Reference Formulation Dose A
Elecoglipron tablets will be administered orally.
의약품: Elecoglipron Test formulation 1 Dose A
Elecoglipron tablets will be administered orally.
실험적: Cohort 2 - Treatment Sequence C
Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose B) in Period 2.
의약품: Elecoglipron Reference Formulation Dose B
Elecoglipron tablets will be administered orally.
의약품: Elecoglipron Test formulation 1 Dose B
Elecoglipron tablets will be administered orally.
실험적: Cohort 2 - Treatment Sequence D
Participant will receive a single dose of elecoglipron test formulation 1 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2.
의약품: Elecoglipron Reference Formulation Dose B
Elecoglipron tablets will be administered orally.
의약품: Elecoglipron Test formulation 1 Dose B
Elecoglipron tablets will be administered orally.
실험적: Cohort 3 - Treatment Sequence E
Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose A) in Period 2.
의약품: Elecoglipron Reference Formulation Dose A
Elecoglipron tablets will be administered orally.
의약품: Elecoglipron Test formulation 2 Dose A
Elecoglipron tablets will be administered orally.
실험적: Cohort 3 - Treatment Sequence F
Participant will receive a single dose of elecoglipron test formulation 2 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2.
의약품: Elecoglipron Reference Formulation Dose A
Elecoglipron tablets will be administered orally.
의약품: Elecoglipron Test formulation 2 Dose A
Elecoglipron tablets will be administered orally.
실험적: Cohort 4 - Treatment Sequence G
Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose B) in Period 2.
의약품: Elecoglipron Reference Formulation Dose B
Elecoglipron tablets will be administered orally.
의약품: Elecoglipron Test formulation 2 Dose B
Elecoglipron tablets will be administered orally.
실험적: Cohort 4 - Treatment Sequence H
Participant will receive a single dose of elecoglipron test formulation 2 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2.
의약품: Elecoglipron Reference Formulation Dose B
Elecoglipron tablets will be administered orally.
의약품: Elecoglipron Test formulation 2 Dose B
Elecoglipron tablets will be administered orally.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Maximum observed drug concentration (Cmax)
기간: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
기간: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Area under concentration-time curve from time 0 to infinity (AUCinf)
기간: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Time to reach maximum observed concentration (tmax)
기간: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Terminal elimination rate constant (λz)
기간: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Terminal elimination half-life (t1/2λz)
기간: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Apparent total body clearance (CL/F)
기간: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Apparent volume of distribution based on the terminal phase (Vz/F)
기간: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf)
기간: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast)
기간: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax)
기간: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
At pre-defined intervals from Day 1 to Day 15

2차 결과 측정

결과 측정
측정값 설명
기간
Number of participants with adverse events (AEs)
기간: From screening (Day -28) up to follow-up visit (Day 18-Day 22)
To assess the safety and tolerability of different formulations of elecoglipron following single oral administration in healthy participants.
From screening (Day -28) up to follow-up visit (Day 18-Day 22)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

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)

2026년 7월 27일

기본 완료 (추정된)

2026년 11월 18일

연구 완료 (추정된)

2026년 11월 18일

연구 등록 날짜

최초 제출

2026년 7월 20일

QC 기준을 충족하는 최초 제출

2026년 7월 20일

처음 게시됨 (실제)

2026년 7월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 15일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D7260C00023

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD 공유 기간

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 공유 액세스 기준

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

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. .

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