A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of AZD4954 and Vice Versa in Healthy Adults

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAstraZeneca

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • AZD4954

    Drug

    AZD4954 will be administered orally.

  • Laroprovstat

    Drug

    Laroprovstat will be administered orally.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Cohort 1: Treatment Sequence ACExperimental treatment 2 interventions
Group B: Cohort 2: Treatment Sequence BCExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Cohort 1: Day 1 to Day 41
2

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.

Time frame
Cohort 1: Day 1 to Day 41
3

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.

Time frame
Cohort 2: Day 1 to Day 25
4

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.

Time frame
Cohort 2: Day 1 to Day 25

Secondary outcomes

1

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.

Time frame
Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31
2

Apparent total body clearance (CL/F) of AZD4954

To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.

Time frame
Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31
3

Terminal elimination half-life (t½λz) of AZD4954

To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.

Time frame
Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31
4

Time to reach maximum observed concentration (tmax) of AZD4954

To describe the PK of AZD4954 when administered alone and in combination with laroprovstat.

Time frame
Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.