About this trial
The purpose this study is to measure the impact of laroprovstat (AZD0780) on the pharmacokinetics (PK) of AZD4954 and the impact of AZD4954 on the PK of laroprovstat in healthy male and female participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All females must have a negative pregnancy test at the Screening Visit.
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 as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
Disqualifiers
History of any clinically important disease or disorder.
History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
Participants with known bleeding or coagulation disorders.
Trial design
Parallel
Treatments tested in this trial
AZD4954
DrugAZD4954 will be administered orally.
Laroprovstat
DrugLaroprovstat will be administered orally.
Treatment groups
Trial outcomes
Primary outcomes
Area under concentration time curve from time 0 to infinity (AUCinf) of AZD4954
To assess the effect of a single dose of oral laroprovstat on the PK of a single dose of oral AZD4954 in healthy participants.
Maximum observed drug concentration (Cmax) of AZD4954
To assess the effect of a single dose of oral laroprovstat on the PK of a single dose of oral AZD4954 in healthy participants.
AUCinf of laroprovstat
To assess the effect of a single dose of oral AZD4954 on the PK of a single dose of oral laroprovstat in healthy participants.
Cmax of laroprovstat
To assess the effect of a single dose of oral AZD4954 on the PK of a single dose of oral laroprovstat in healthy participants.
Secondary outcomes
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) of AZD4954
To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.
Apparent total body clearance (CL/F) of AZD4954
To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.
Terminal elimination half-life (t½λz) of AZD4954
To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.
Time to reach maximum observed concentration (tmax) of AZD4954
To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.