Drug-drug Interaction Study of Rosuvastatin and AT-527 (R07496998)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2021-12-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Drug-drug interaction study of rosuvastatin and AT-527 (R07496998)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Drug Interaction Study Between Simvastatin, Atorvastatin, Rosuvastatin, and GSK2248761 in Healthy Subjects.

NCT01138072

Infection, Human Immunodeficiency Virus

COMPLETED PHASE1

Study of PF-04965842 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants

NCT03806101

Healthy

COMPLETED PHASE1

Drug Interaction Statin

NCT02089061

Acute Coronary Syndromes

COMPLETED PHASE1

Assessment of the Lipid Lowering Effect of Rosuvastatin Compared to Atorvastatin in Subjects With Coronary Heart Disease

NCT00235950

Coronary Heart Disease

COMPLETED PHASE4

Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia

NCT00683618

Hypercholesterolemia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer Study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AT-527 + rosuvastatin (simultaneous) n=14

Group Type EXPERIMENTAL

Drug: AT-527 + rosuvastatin

Intervention Type DRUG

* Day 1: A single dose of rosuvastatin will be administered.
* Day 8: A single dose of AT-527 and rosuvastatin will be co-administered.

AT-527 + rosuvastatin (staggered) n=14

Group Type EXPERIMENTAL

AT-527 + rosuvastatin

Intervention Type DRUG

* Day 1: A single dose of rosuvastatin will be administered.
* Day 8: A single staggered dose of AT-527 and rosuvastatin will be administered (2 hours later)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Drug: AT-527 + rosuvastatin

* Day 1: A single dose of rosuvastatin will be administered.
* Day 8: A single dose of AT-527 and rosuvastatin will be co-administered.

Intervention Type DRUG

AT-527 + rosuvastatin

* Day 1: A single dose of rosuvastatin will be administered.
* Day 8: A single staggered dose of AT-527 and rosuvastatin will be administered (2 hours later)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AT-527 is also know as R07496998 AT-527 is also know as R07496998

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Concomitant use of prescription medications, or systemic over-the-counter medications
* Other clinically significant medical conditions or laboratory abnormalities

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes