NCT07423598
Recruiting
Phase 1
A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 Following Repeated Dose Administration to Healthy Adults With Elevated LDL-C Levels
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Relative change from baseline in LDL-C levels
Overview
Brief Summary
The purpose of this study is to evaluate pharmacodynamics (PD) of AZD0780 compared with placebo by assessment of low-density lipoprotein-cholesterol (LDL-C) levels following repeated oral dosing in healthy adults with elevated LDL-C levels.
Detailed Description
This is a Phase I, randomized, single-blind, placebo-controlled study of AZD0780 in healthy adults with elevated LDL-C levels.
The study comprises of:
- An optional Pre-screening visit.
- A Screening Period (maximum 28 days).
- Admission to the Clinical Unit (Day -1).
- A Treatment Period for administration of AZD0780 or placebo (Days 1 to 28).
- Follow-up Visit 12 ± 2 days after the last study intervention dose.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy participants with suitable veins for cannulation or repeated venipuncture.
- •All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- •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.
- •Have a body mass index between 18 and 35 kg/m2 inclusive and weigh at least 50 kg.
- •Fasting LDL-C ≥ 70 mg/dL and \< 190 mg/dL at Screening.
Exclusion Criteria
- •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.
- •Any abnormal vital signs or laboratory values including clinical chemistry, hematology, coagulation, or urinalysis results.
- •Current smokers or those who have smoked or used nicotine products (including e-cigarettes) or any known or suspected history of alcohol or drug abuse.
- •History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, especially to drugs with a similar chemical structure or class to AZD0780.
Arms & Interventions
Placebo
Placebo Comparator
Participants will receive a dose of matching placebo to AZD0780
Intervention: Placebo (Drug)
AZD0780
Experimental
Participants will receive a dose of AZD0780.
Intervention: AZD0780 (Drug)
Outcomes
Primary Outcomes
Relative change from baseline in LDL-C levels
Time Frame: From Baseline (Day 1) to 4 weeks
To determine the pharmacodynamic profile of AZD0780 versus placebo by evaluating LDL-C concentrations after repeated oral administration
Secondary Outcomes
- Area under concentration-time curve from time 0 to infinity (AUCinf)(At pre-defined intervals from Day 1 to Day 40)
- Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)(At pre-defined intervals from Day 1 to Day 40)
- Maximum observed drug concentration (Cmax)(At pre-defined intervals from Day 1 to Day 40)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(Upto Day 40)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD3974 in Healthy ParticipantsNCT07290283AstraZeneca176
Not yet recruiting
Phase 3
A Study to Find Out How Safe and Well AZD0780 Works for Adults with High 'Bad' Cholesterol and with Heart- Stroke or Vascular Disease or at risk for Such Disease2025-520521-21-00AstraZeneca AB780
Not yet recruiting
Phase 3
A Study to Find Out How Safe and Effective AZD0780 Is for Adults with High 'Bad' Cholesterol from an Inherited Condition2025-520520-17-00AstraZeneca AB152
Recruiting
Phase 2
A Phase IIb Two-Cohort, Randomised, Placebo controlled, Double blind, Multi-centre, Dose-ranging Study of AZD5462 in Stable Patients with Chronic Heart Failure2023-510148-19-00AstraZeneca AB235
Recruiting
Phase 2
Phase 2a Study to Assess the Efficacy and Safety of AZD4604 in Adult Patients with Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA2023-506000-50-00Astrazeneca AB124