Study of AT-527 in Healthy and HCV-Infected Subjects

Hepatitis C Clinical Trial

Official title:

A Phase I Study Assessing Single and Multiple Doses of AT-527 in Healthy and HCV-Infected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219957
• Other study ID #: AT-01B-001
• Status: Completed
• Phase: Phase 1
• Start date: July 6, 2017
• Est. completion date: June 20, 2018

Study information

• Verified date: February 2020
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In addition, the study will assess the antiviral activity of AT-527 in subjects infected with HCV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 20, 2018
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

All subjects (healthy and HCV-infected subjects):

• Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug

• Must have a negative pregnancy test at Screening and prior to dosing

• Minimum body weight of 50 kg

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

Additional inclusion criteria for HCV-infected subjects:

• Must have not received prior treatment for HCV infection

• Documented clinical history compatible with chronic HCV infection

• Plasma HCV RNA = 5.0 log10 IU/mL at Screening.

Exclusion Criteria:

All subjects (healthy and HCV-infected subjects):

• Pregnant or breastfeeding

• Infected with hepatitis B virus or HIV

• Abuse of alcohol or drugs

• Use of other investigational drugs within 28 days of dosing

• Other clinically significant medical conditions or laboratory abnormalities

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• AT-527
Ascending doses of AT-527 administered orally.

Other:
• Placebo Comparator
Matching placebo

Locations

Country	Name	City	State
Belgium	Clinical Trial Site	Antwerp
Moldova, Republic of	Clinical Trial Site	Chisinau

Sponsors (1)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Belgium,  Moldova, Republic of, 

References & Publications (1)

Berliba E, Bogus M, Vanhoutte F, Berghmans PJ, Good SS, Moussa A, Pietropaolo K, Murphy RL, Zhou XJ, Sommadossi JP. Safety, pharmacokinetics and antiviral activity of AT-527, a novel purine nucleotide prodrug, in HCV-infected subjects with and without cir — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Number of subjects experiencing treatment-emergent adverse events	Through Day 6 for subjects receiving a single dose
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Number of subjects experiencing treatment-emergent adverse events	Through Day 35 for subjects receiving multiple doses.
Secondary	Pharmacokinetics (PK) of AT-527	Maximum plasma concentration (Cmax)	Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses
Secondary	Pharmacokinetics (PK) of AT-527	Area under the concentration-time curve (AUC)	Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses
Secondary	Antiviral Activity of AT-527	Change from baseline in plasma HCV RNA	Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses.