Calendario›GILD›Cilofexor
Cilofexor
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
Ensayo de GILEAD SCIENCES, INC. en Esteatohepatitis no alcoholica.
Más ensayos de: Esteatohepatitis no alcohólica.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 120
- Centros
- 1
- Fin del objetivo primario
- jul 2016
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en ene 2016.
Qué mide
Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor (Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants will receive either cilofexor or cilofexor placebo. Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative, blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be initiated in parallel with cohorts in Part A if the total dose under evaluation is at or below a dose already evaluated. This study is partially blinded (no one is blinded on Day -1).
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Todos los de GILD, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02654002), actualizada en sep 2020.