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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03219957
Other study ID # AT-01B-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


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.
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