Calendario›VTGN›AV-101

AV-101

AV-101 Alone and in Combination With Probenecid in Healthy Subjects

Ensayo de Vistagen Therapeutics, Inc. en Drug Drug Interaction (del registro, en inglés).

Fase

Fase 1

Estado

Sin noticias del promotor

Participantes

24

previstos

Centros

1

Fin del objetivo primario

sep 2022

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en dic 2021.

Qué mide

Plasma and CSF concentrations of 7-chloro-kynurenic acid (7-Cl-KYNA) in ng/ml (del registro, en inglés) (24 horas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open-label, two period, fixed-sequence, drug-drug interaction study to compare the PK and PD of orally administered AV-101 alone and in combination with probenecid in healthy subjects. In Treatment Period 1, subjects will receive AV-101 following an overnight fast of at least 8 hours. In Treatment Period 2, subjects will fast overnight for at least 8 hours, and then receive AV-101 2 hours after receiving 1,000 mg probenecid. Each Treatment Period will be separated by a washout period. The doses of AV-101 in Cohort 1 and a possible Cohort 2 will be 360 mg and 720 mg, respectively. Optional Cohorts 3 and 4 may be enrolled depending on results from Cohorts 1 and 2. CSF will be collected via indwelling catheter to determine the PK of AV-101 and its active metabolite 7-Cl-KYNA.

Más ensayos de VTGN

Todos los de VTGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05280054), actualizada en mar 2022.