Healthy Volunteer StudyPhase 1NCT04849299
Effect of Cyclosporine on the Pharmacokinetics (PK) of AT-527 (R07496998)
A Phase 1 study testing AT-527 550 mg + cyclosporine in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
This study will determine the effect of cyclosporine on the PK of AT-527 (R07496998) in healthy male subjects Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- AT-527 550 mg + cyclosporine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 18 Apr 2021to 10 May 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
- Men only
- 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
- 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, Randomized, Open-Label Study to Evaluate the Effect of Cyclosporine on the Plasma Pharmacokinetics of AT-527 in Healthy Adult Male Subjects
This study will determine the effect of cyclosporine on the PK of AT-527 (R07496998) in healthy male subjects
- Conditions
- Healthy Volunteer Study
- Being tested
- AT-527 550 mg + cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-527 550 mg + cyclosporineDrug
550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered simultaneously on Day 7 Other Names: AT-527 is also known as R07496998
AT-527 550 mg + cyclosporineDrug
550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered on Day 7 (with dosing offset by 2 hrs) Other Names: AT-527 is also known as R07496998
| Study group | Role | What they receive |
|---|---|---|
| AT-527 550 mg + cyclosporine (simultaneous) | Experimental | n=12 Receives: Drug: AT-527 550 mg + cyclosporine |
| AT-527 550 mg + cyclosporine (staggered) | Experimental | n=12 Receives: Drug: AT-527 550 mg + cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of AT-527 (R07496998): Cmax
Maximum plasma concentration (Cmax)
Measured: Day 1 vs Day 7
Pharmacokinetics (PK) of AT-527 (R07496998): AUC
Area under the concentration-time curve (AUC)
Measured: Day 1 vs Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start18 Apr 2021
- Primary completion10 May 2021
- Study completion10 May 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT04849299
- Sponsor's protocol ID
- AT-03A-005
- Status last verified
- Jul 2021
- First submitted
- 14 Apr 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No