A Five-in-One First-in-Human Study To Assess Safety, Tolerability, and Pharmacokinetics of RO7049389, an Inhibitor of Hepatitis B Virus Capsid Assembly, after Single and Multiple Ascending Doses in Healthy Participants.
RO7049389
drug-drug interaction
first in human
first-in-human study
hepatitis B virus
pharmacokinetics
safety
Journal
Antimicrobial agents and chemotherapy
ISSN: 1098-6596
Titre abrégé: Antimicrob Agents Chemother
Pays: United States
ID NLM: 0315061
Informations de publication
Date de publication:
20 10 2020
20 10 2020
Historique:
received:
25
06
2020
accepted:
17
08
2020
pubmed:
26
8
2020
medline:
22
6
2021
entrez:
26
8
2020
Statut:
epublish
Résumé
RO7049389, an inhibitor of hepatitis B virus (HBV) capsid assembly, is being developed for the treatment of patients with chronic HBV infection. The objectives of this first-in-human study are to assess the safety, tolerability, pharmacokinetics (PK), food effect, inhibitory effect on CYP3A, and effect on QT of RO7049389 in healthy participants. Five components, single-ascending-dose (SAD) cohorts, multiple-ascending-dose (MAD) cohorts, food effect assessment, drug-drug interaction assessment, and concentration-QT analysis were integrated in one study (five-in-one). Participants randomly received a single dose of 150 to 2,500 mg RO7049389 or placebo in SAD cohorts (
Identifiants
pubmed: 32839221
pii: AAC.01323-20
doi: 10.1128/AAC.01323-20
pmc: PMC7577148
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02952924']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2020 American Society for Microbiology.
Références
Clin Pharmacol Ther. 2013 Jun;93(6):564-71
pubmed: 23511711
J Hepatol. 2017 Aug;67(2):370-398
pubmed: 28427875