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Nucleotide Analog

Group 1 -Mild Hepatic Impairment for Liver Disease

Phase 1
Recruiting
Research Sponsored by Atea Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights

Study Summary

This trial studies how liver function affects how the drug bemnifosbuvir works in people with liver disease.

Who is the study for?
This trial is for adults with liver disease or healthy individuals who are willing to follow study rules and consent. Participants must have stable liver function, match certain age, gender, BMI criteria, and not be pregnant or breastfeeding. They should not have uncontrolled diabetes, active infections like hepatitis or HIV, a history of alcohol/drug abuse, recent use of other investigational drugs, or significant medical issues.Check my eligibility
What is being tested?
The study tests how a single dose of Bemnifosbuvir (BEM) affects people with different levels of liver health. It compares the drug's behavior in those with normal liver function to those with mild to severe impairment.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally could include reactions at the site where the drug is administered (if injectable), gastrointestinal symptoms like nausea or diarrhea, allergic reactions, fatigue or changes in blood tests that monitor liver function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics (PK) of BEM AUC
Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)
Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)

Trial Design

5Treatment groups
Experimental Treatment
Group I: Group 5 - Normal hepatic function matching severe impairment groupExperimental Treatment1 Intervention
Drug: single dose Bemnifosbuvir (BEM)
Group II: Group 4 - Severe Hepatic ImpairmentExperimental Treatment1 Intervention
Drug: single dose Bemnifosbuvir (BEM)
Group III: Group 3 - Healthy Subjects matching mild and moderate impairment groupsExperimental Treatment1 Intervention
Drug: single dose Bemnifosbuvir (BEM)
Group IV: Group 2-Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Drug: single dose Bemnifosbuvir (BEM)
Group V: Group 1 -Mild Hepatic ImpairmentExperimental Treatment1 Intervention
Drug: single dose Bemnifosbuvir (BEM)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bemnifosbuvir (BEM)
2023
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Atea Pharmaceuticals, Inc.Lead Sponsor
27 Previous Clinical Trials
3,992 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria for this medical trial encompass individuals under thirty years of age?

"This trial is accepting individuals aged 18 and over, but under 80 years of age."

Answered by AI

Could I be eligible to enroll in this research project?

"Candidates must meet certain eligibility criteria, namely healthy subjects and an age range between 18 and 80. There are 40 positions to fill for this clinical trial."

Answered by AI

Is registration for this clinical experiment still open?

"Yes, the clinical trial is presently searching for participants. Clinicaltrials.gov shows that this research was originally published on January 30th 2023 and has since been revised on February 2nd 2023."

Answered by AI

Has the Federal Drug Administration sanctioned Group 1 - Mild Hepatic Impairment?

"Due to the limited data backing up efficacy and safety, Group 1 - Mild Hepatic Impairment received a score of 1 from our Power team."

Answered by AI

How many individuals are actively engaging in this clinical research initiative?

"Affirmative, the information available on clinicaltrials.gov reveals that this investigation is still actively seeking applicants. The research project was initially posted on January 30th 2023 and underwent its most recent update two days later. Forty people are being recruited for the trial at a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function
2023. "Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05724693.
~18 spots leftby Apr 2025
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