Clinical trial NCT06105255: A Study to Evaluate the Effects of D-1553 on PK of Midazolam, Caffeine, Rosuvastatin, Furosemide, Digoxin, and Itraconazole or Omeprazole on PK of D-1553
Official title: A Phase I Study to Evaluate the Effects of Multiple-dose D-1553 on Pharmacokinetics of Single-dose Midazolam, Caffeine, Rosuvastatin, Furosemide and Digoxin, and to Evaluate the Effects of Multiple-dose Itraconazole and Omeprazole on Pharmacokinetics of Single-dose D-1553 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a phase I study to evaluate drug-drug interactions (DDIs) of D-1553 as a perpetrator combined with midazolam (CYP3A4 substrate), caffeine (CYP1A2 substrate), rosuvastatin (OATP1B1/OATP1B3 substrate), furosemide (OAT1/OATP1B3 substrate), and digoxin (P-gp substrate) and to evaluate DDIs of D-1553 as a victim combined with itraconazole (inhibitor of CYP3A4 and P-gp) and omeprazole (proton-pump inhibitor) in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects who volunteer to participate in this clinical trial, understand the study procedures and sign the Informed Consent Form (ICF) in writing.
* Male, aged 18-45 years (both inclusive) at the time of signing the ICF.
* Non-smokers or subjects who smoked no more than 5 cigarettes or 1 pipe per day within 3 months prior to screening.

Exclusion Criteria:

* Subjects with any clinically significant acute diseases as judged by the investigators within one month prior to screening.
* Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody.
* Subjects with a history of blood or needle phobia.
* Subjects with a history of hypersensitivity to the investigational drug and/or any preparation ingredients.

Primary outcomes:
measure: Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: maximum concentration (Cmax).
timeFrame: Before and after co-administration of D-1553, approximately day1 and day10
measure: Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: area under the concentration-time curve from the time of dosing to time t (AUC0-t).
timeFrame: Before and after co-administration of D-1553, approximately day1 and day10
measure: Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: area under the concentration-time curve from time 0 to infinity (AUC0-∞).
timeFrame: Before and after co-administration of D-1553, approximately day1 and day10
measure: Primary PK parameters of D-1553: maximum concentration (Cmax).
timeFrame: Before and after co-administration of itraconazole, approximately day1 and day9
measure: Primary PK parameters of D-1553: area under the concentration-time curve from the time of dosing to time t (AUC0-t).
timeFrame: Before and after co-administration of itraconazole, approximately day1 and day9
measure: Primary PK parameters of D-1553: area under the concentration-time curve from time 0 to infinity (AUC0-∞).
timeFrame: Before and after co-administration of itraconazole, approximately day1 and day9
measure: Primary PK parameters of D-1553: maximum concentration (Cmax).
timeFrame: Before and after co-administration of omeprazole, approximately day1 and day8
measure: Primary PK parameters of D-1553: area under the concentration-time curve from the time of dosing to time t (AUC0-t).
timeFrame: Before and after co-administration of omeprazole, approximately day1 and day8
measure: Primary PK parameters of D-1553: area under the concentration-time curve from time 0 to infinity (AUC0-∞).
timeFrame: Before and after co-administration of omeprazole, approximately day1 and day8
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui District Central Hospital
state: Shanghai
Study officials:
References: