Healthy Volunteer StudyPhase 1NCT05154123
Drug-drug Interaction Study of Rosuvastatin and AT-527 (R07496998)
A Phase 1 study testing Drug: AT-527 + rosuvastatin and AT-527 + rosuvastatin in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
Drug-drug interaction study of rosuvastatin and AT-527 (R07496998) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- Drug: AT-527 + rosuvastatin and AT-527 + rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 16 Nov 2021to 23 Dec 2021
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Effect of AT-527 on the Pharmacokinetics of Rosuvastatin in Healthy Adult Subjects
Drug-drug interaction study of rosuvastatin and AT-527 (R07496998)
- Conditions
- Healthy Volunteer Study
- Being tested
- Drug: AT-527 + rosuvastatin, AT-527 + rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: AT-527 + rosuvastatinDrug
Also called AT-527 is also know as R07496998
- 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 + rosuvastatinDrug
Also called AT-527 is also know as R07496998
- 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)
| Study group | Role | What they receive |
|---|---|---|
| AT-527 + rosuvastatin (simultaneous) n=14 | Experimental | Not described Receives: Drug: Drug: AT-527 + rosuvastatin |
| AT-527 + rosuvastatin (staggered) n=14 | Experimental | Not described Receives: Drug: AT-527 + rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of co-administration of AT-527 on the single-dose pharmacokinetics (PK) of rosuvastatin
Maximum plasma concentration (Cmax)
Measured: Day 1, Day 8
To evaluate the effect of co-administration of AT-527 on the single-dose pharmacokinetics (PK) of rosuvastatin
Area under the concentration-time curve (AUC)
Measured: Day 1, Day 8
To determine the effect of a staggered dose of AT-527 administered 2 hours before rosuvastatin on the PK of rosuvastatin
Area under the concentration-time curve (AUC)
Measured: Day 1, Day 8
To determine the effect of a staggered dose of AT-527 administered 2 hours before rosuvastatin on the PK of rosuvastatin
Maximum plasma concentration (Cmax)
Measured: Day 1, Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start16 Nov 2021
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154123
- Sponsor's protocol ID
- AT-03A-012
- Status last verified
- Oct 2021
- First submitted
- 16 Nov 2021
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No