Healthy Volunteer Clinical Trial
Official title:
An Open Label, 2-Period Study to Assess the Effect of Entinostat on the Pharmacokinetics of Midazolam in Healthy Adult Subjects
The purpose of this study is to evaluate the effect of Entinostat on the bioavailability of
Midazolam.
The primary objective is to evaluate the effect of a single oral dose of entinostat on the
pharmacokinetics (PK) of a single oral dose of midazolam in healthy subjects.
The secondary objective is to evaluate the safety and tolerability of combined administration
of entinostat and midazolam in healthy subjects.
This is an open label, 2 period, fixed-sequence study.
Twenty-two (22), healthy, adult male subjects will be enrolled; additional subjects may be
enrolled to replace discontinued subjects, at the discretion of the Sponsor.
Screening of subjects will occur within 28 prior to the first dose.
On Day 1 of Period 1, a single oral dose of midazolam will be administered followed by PK
sampling for midazolam and 1 OH midazolam for 24 hours.
On Day 1 of Period 2, a single oral dose of midazolam will be administered 0.75 hours after a
single oral dose of entinostat. Following midazolam dosing on Day 1 of Period 2, PK samples
for midazolam and 1 OH midazolam will be taken for 24 hours.
There will be a washout period of at least 7 days between the dosing in Period 1 and
entinostat dose in Period 2.
Safety will be monitored throughout the study by repeated clinical and laboratory
evaluations.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06326723 -
Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT00001367 -
Diagnosis and History Study of Patients With Different Neurological Conditions
|
||
| Completed |
NCT02699710 -
Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02231892 -
Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study
|
N/A | |
| Not yet recruiting |
NCT06441916 -
Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions
|
Phase 1 | |
| Completed |
NCT03771586 -
A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
|
Phase 1 | |
| Not yet recruiting |
NCT06337422 -
Bioequivalence Study of Generic Celecoxib 200 mg Capsules
|
Phase 1 | |
| Completed |
NCT03302182 -
Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT05049343 -
Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants
|
Phase 1 | |
| Recruiting |
NCT01629108 -
Normal Values in Hearing and Balance Testing
|
||
| Completed |
NCT02947854 -
Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant
|
Phase 1 | |
| Completed |
NCT02534870 -
Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT02224053 -
Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01676584 -
A Study of Single Dose RO6811135 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01697436 -
A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
|
Phase 1 | |
| Completed |
NCT01711762 -
A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT01684891 -
A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT01461967 -
A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01579149 -
A Phase I Dose Escalation Study of Plerixafor in Healthy Subjects of Japanese Descent
|
Phase 1 | |
| Completed |
NCT01433575 -
A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers
|
Phase 1 |