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

Sponsor

Atea Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03219957

Collaborator

(none)

Enrollment

Locations

Arms

11.5

Actual Duration (Months)

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Hepatitis C Hepatitis C, Chronic	Drug: AT-527 Other: Placebo Comparator	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 6, 2017

Actual Primary Completion Date :

Jun 20, 2018

Actual Study Completion Date :

Jun 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AT-527	Drug: AT-527 Ascending doses of AT-527 administered orally.
Placebo Comparator: Placebo	Other: Placebo Comparator Matching placebo

Arm

Intervention/Treatment

Experimental: AT-527

Drug: AT-527

Ascending doses of AT-527 administered orally.

Placebo Comparator: Placebo

Other: Placebo Comparator

Matching placebo

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Through Day 6 for subjects receiving a single dose]
Number of subjects experiencing treatment-emergent adverse events
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Through Day 35 for subjects receiving multiple doses.]
Number of subjects experiencing treatment-emergent adverse events

Secondary Outcome Measures

Pharmacokinetics (PK) of AT-527 [Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses]
Maximum plasma concentration (Cmax)
Pharmacokinetics (PK) of AT-527 [Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses]
Area under the concentration-time curve (AUC)
Antiviral Activity of AT-527 [Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses.]
Change from baseline in plasma HCV RNA

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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