A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood
1상
완료
NCT05945888
| 대상 질환 | Healthy |
|---|
| 임상 단계 | 1상 |
|---|
| 스폰서 | Boehringer Ingelheim |
|---|
| 상태 | 완료 |
|---|
| 참여자 수 | 68 명 |
|---|
| 중재(약물) | BI 3000202, Placebo matching BI 3000202 |
|---|
| 시작일 | 2023년 7월 25일 |
|---|
| 완료일 | 2023년 11월 13일 |
|---|
| 결과 공개일 | 2026년 6월 8일 |
|---|
요약
The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202. The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.
SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator
From drug administration on Day 1 plus REP of 48 hours, up to 2 days. · Participants
| Single Rising Dose (SRD): Placebo Matching BI 3000202 | 1 Participants |
|---|
| SRD: Dose 1 - BI 3000202 | 0 Participants |
|---|
| SRD: Dose 2 - BI 3000202 | 0 Participants |
|---|
| SRD: Dose 3 - BI 3000202 | 1 Participants |
|---|
| SRD: Dose 4 - BI 3000202 | 0 Participants |
|---|
| SRD: Dose 5 - BI 3000202 | 0 Participants |
|---|
FE Part: Area Under the Concentration-time Curve of BI 3000202 in Plasma Over the Dosing Interval 0 to 24 Hours (AUC0-24)
Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration · Nanomoles times hour per Liter
| Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R) | 901.43 ± NA Nanomoles times hour per Liter |
|---|
| FE Part: Low Dose III BI 3000202 Fed (= Test T) | 768.45 ± NA Nanomoles times hour per Liter |
|---|
| Geometric mean ratio (T/R) [%] | 85.25 (95% CI 71.74–101.30) |
|---|
FE Part: Maximum Measured Concentration of BI 3000202 in Plasma (Cmax)
Within 3 hours (h) prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48 h after drug administration · Nanomoles per Liter
| Food Effect (FE): Low Dose III BI 3000202 Fasted (= Reference R) | 229.43 ± NA Nanomoles per Liter |
|---|
| FE Part: Low Dose III BI 3000202 Fed (= Test T) | 219.06 ± NA Nanomoles per Liter |
|---|
| Geometric mean ratio (T/R) [%] | 95.48 (95% CI 65.40–139.41) |
|---|
BENITIONS에서 보기
ClinicalTrials.gov 원문 보기
전체 임상
이 페이지는 ClinicalTrials.gov의 공개 데이터를 정리한 것입니다. 의학적 조언이 아니며 투자 권유나 자문도 아닙니다. 반드시 전문의와 상담하세요.