Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects

Hepatitis C Clinical Trial

Official title:

A Phase I/IIa Study Assessing AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04309734
• Other study ID #: AT-01C-001
• Secondary ID: 2019-004997-24
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: October 2021
• Est. completion date: September 2022

Study information

• Verified date: June 2022
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

All:

• Body mass index (BMI) of 18-35 kg/m2

• Must agree to use protocol-specified methods of contraception

• Negative pregnancy test

• Willing to comply with the study requirements and to provide written informed consent

Additional for Part A:

-18-55 years of age

Additional for Part B:

• 18-65 years of age

• HCV genotype 1, 2 or 3

• Documented history compatible with chronic hepatitis C

• HCV RNA = 10,000 IU/mL at Screening

Exclusion Criteria:

All:

• Pregnant or breastfeeding

• Abuse of alcohol or drugs

• Use of other investigational drugs within 30 days of dosing

• Other clinically significant medical conditions

Additional for Part B:

• Prior exposure to any HCV NS5A inhibitor

• Cirrhosis

• Co-infection with hepatitis B virus or HIV

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Communicable Diseases
• HCV Infection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Hepatitis C, Chronic
• Infections

Intervention

Drug:
• AT-777
Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.
• Placebo
Administered orally, as one or two placebo capsules, depending on the arm.
• AT-527
Administered orally as one 550 mg tablet of AT-527 (nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase), depending on the arm.

Locations

Country	Name	City	State
Belgium	Clinical Trial Site	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Number of subjects experiencing treatment-emergent adverse events	Through Day 6 for subjects in Part A
Primary	Incidence of Treatment-Emergent Adverse Events	Number of subjects experiencing treatment-emergent adverse events	Through 4 weeks after end of treatment for subjects in Part B
Primary	Antiviral Activity of AT-777 and AT-527	Number of subjects who achieve plasma HCV RNA < lower limit of quantitation (LLOQ) and target not detected (TND)	Through 2 weeks of treatment for subjects in Part B
Secondary	AT-777 maximum plasma concentration (Cmax)	PK	Day 1 for subjects in Part A
Secondary	AT-777 area under the concentration-time curve (AUC)	PK	Day 1 for subjects in Part A
Secondary	Proportion of subjects achieving sustained virologic response (SVR)	SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment	12 weeks after end of treatment for subjects in Part B