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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.
This is an open-label, fixed-sequence, 2 period and 2 cohort study in healthy participants.
Each participant in each cohort will receive treatments in a fixed order during the 2 treatment periods as follows:
The following treatments will be given during the study:
The study will comprise of a Screening Period, two Treatment Periods and follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Treatment Sequence AC | Experimental | Participant will receive single dose of AZD4954 alone (Treatment A) followed by single doses of laroprovstat+AZD4954 (Treatment C). |
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| Cohort 2: Treatment Sequence BC | Experimental | Participant will receive single dose of laroprovstat alone (Treatment B) followed by single doses of laroprovstat+AZD4954 (Treatment C). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4954 | Drug | AZD4954 will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Cohort 1: Day 1 to Day 41 |
| 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. | Cohort 1: Day 1 to Day 41 |
| 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. | Cohort 2: Day 1 to Day 25 |
| 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. | Cohort 2: Day 1 to Day 25 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31 |
| Apparent total body clearance (CL/F) of AZD4954 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Glendale | California | 91206 | United States |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
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| Laroprovstat | Drug | Laroprovstat will be administered orally. |
|
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To describe the PK of AZD4954 when administered alone and in combination with laroprovstat. |
| Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31 |
| Terminal elimination half-life (t½λz) of AZD4954 | To describe the PK of AZD4954 when administered alone and in combination with laroprovstat. | Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31 |
| Time to reach maximum observed concentration (tmax) of AZD4954 | To describe the PK of AZD4954 when administered alone and in combination with laroprovstat. | Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31 |
| Time of last quantifiable concentration (tlast) of AZD4954 | To describe the PK of AZD4954 when administered alone and in combination with laroprovstat. | Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31 |
| Time delay between drug administration and the first observed concentration (tlag) of AZD4954 | To describe the PK of AZD4954 when administered alone and in combination with laroprovstat. | Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31 |
| Apparent volume of distribution based on the terminal phase (Vz/F) of AZD4954 | To describe the PK of AZD4954 when administered alone and in combination with laroprovstat. | Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31 |
| AUClast of laroprovstat | To describe the PK of laroprovstat when administered alone and in combination with AZD4954. | Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25 |
| CL/F of laroprovstat | To describe the PK of laroprovstat when administered alone and in combination with AZD4954. | Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25 |
| t½λz of laroprovstat | To describe the PK of laroprovstat when administered alone and in combination with AZD4954. | Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25 |
| tmax of laroprovstat | To describe the PK of laroprovstat when administered alone and in combination with AZD4954. | Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25 |
| tlast of laroprovstat | To describe the PK of laroprovstat when administered alone and in combination with AZD4954. | Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25 |
| tlag of laroprovstat | To describe the PK of laroprovstat when administered alone and in combination with AZD4954. | Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25 |
| Vz/F of laroprovstat | To describe the PK of laroprovstat when administered alone and in combination with AZD4954. | Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25 |
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | To assess the safety and tolerability of AZD4954 alone and in combination with laroprovstat; and safety and tolerability of laroprovstat alone and in combination with AZD4954 following oral administration of single doses in healthy participants. | Cohort 1: Up to Day 83; Cohort 2: Up to Day 73 |