Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function

Part of paid clinical trials in Orlando, Florida.

Sponsor
Atea Pharmaceuticals, Inc.
Study ID
NCT06911320
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteer Study
  • Hepatic Impairment
  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination — DRUG
    A single dose of BEM/RZR will be administered

Study Details

To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose

Key Dates

Start date
Apr 9, 2025
Status verified
May 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 - Severe Renal Impairment
    Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
  • Experimental: Group 2 - Severe Hepatic Impairment
    Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
  • Experimental: Group 3 - Matched Healthy Subjects
    Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Primary Outcome Measure

Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax) [ Time Frame: Day 1 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Atea Study SiteOrlandoFlorida32809
Atea Study Site
[email protected]
888-481-1607
Atea Study SiteTampaFlorida33603
Atea Study Site
[email protected]
888-481-1607

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