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A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia

ConditionsHealthy ParticipantsDyslipidemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAstraZeneca

About this trial

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4954 in healthy participants with or without elevated Lipoprotein(a) (Lp\[a\]) levels and participants with dyslipidemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with plasminogen level (concentration) within normal range at the Screening Visit.

All females must have a negative pregnancy test at the Screening Visit and on admission to the study site.

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 the Screening Visit.

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

Sequential

Treatments tested in this trial

  • AZD4954

    Drug

    AZD4954 will be administered orally.

  • Placebo

    Drug

    Placebo will be administered orally.

Treatment groups

136 Participants
are divided into 18 treatment groups

18

Treatment groups

See each treatment group below.

Group A: Part A1: SAD Cohort 1 - AZD4954 (Dose 1)Experimental treatment 2 interventions
Group B: Part A1: SAD Cohort 2 - AZD4954 (Dose 2)Experimental treatment 2 interventions
Group C: Part A1: SAD Cohort 3 - AZD4954 (Dose 3)Experimental treatment 2 interventions
Group D: Part A1: SAD Cohort 4 - AZD4954 (Dose 4)Experimental treatment 2 interventions
Group E: Part A1: SAD Cohort 5 - AZD4954 (Dose 5)Experimental treatment 2 interventions
Group F: Part A1: SAD Optional Cohort 6 - AZD4954 (Dose 6)Experimental treatment 2 interventions
Group G: Part A1: SAD Cohort 1 (Japanese) - AZD4954 (Dose 2)Experimental treatment 2 interventions
Group H: Part A1: SAD Cohort 2 (Japanese) - AZD4954 (Dose 3)Experimental treatment 2 interventions
Group I: Part A1: SAD Optional Cohort 3 (Japanese) - AZD4954Experimental treatment 2 interventions
Group J: Part A1: SAD Cohort 1 (Chinese) - AZD4954 (Dose 5)Experimental treatment 2 interventions
Group K: Part A2: SAD Food Effect Cohort - AZD4954 (Dose 2)Experimental treatment 2 interventions
Group L: Part A2: SAD Food Effect Cohort - AZD4954 (Dose 3)Experimental treatment 2 interventions
Group M: Part B: Global MAD Cohort 1 (healthy participants) - AZD4954 (Dose 1)Experimental treatment 2 interventions
Group N: Part B: Global MAD Cohort 2 (healthy participants) - AZD4954 (Dose 2)Experimental treatment 2 interventions
Group O: Part B: Global MAD Cohort 3 (healthy participants) - AZD4954 (Dose 3)Experimental treatment 2 interventions
Group P: Part B: Optional Global MAD Cohort 4 (healthy participants) - AZD4954Experimental treatment 2 interventions
Group Q: Part B: MAD Cohort (Japanese) - AZD4954 (Dose 3)Experimental treatment 2 interventions
Group R: Part B: Global MAD Cohort (participants with dyslipidemia) - AZD4954 (Dose 1)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part A: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

To assess the safety and tolerability of AZD4954 following oral administration of SAD (Part A).

Time frame
From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 29±2 days)
2

Part B: Number of participants with AEs and SAEs

To assess the safety and tolerability of AZD4954 following oral administration of MAD (Part B).

Time frame
From Screening (Day -28 to Day -2) to Follow-up visit (Up to Day 49±2 days)

Secondary outcomes

1

Part A: Area under concentration-time curve from time 0 to infinity (AUCinf)

To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.

Time frame
Up to Day 29±2 days
2

Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.

Time frame
Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days
3

Part B: Area under concentration-time curve in the dosing interval (AUCtau)

To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.

Time frame
Up to Day 49±2 days
4

Dose normalized AUClast (AUClast/D)

To characterize the single dose and/or steady state pharmacokinetics of AZD4954 following oral administration of AZD4954.

Time frame
Part A: Up to Day 29±2 days; Part B: Up to Day 49±2 days

Other outcomes

Sponsors and contacts

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

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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