Healthy Clinical Trial
Official title:
A Phase 1, Open-Label, Single-Sequence Crossover Study in Healthy Subjects to Determine the Effect of Relacorilant on Exposure to Probe Substrates for Cytochrome P450s 3A4, 2C8, 2C9, 2C19, and 2D6
This is an open-label, single-sequence, 3-period crossover study conducted in healthy subjects. Eligible subjects will participate in a single treatment period, in which they will receive the following treatments: Day 1, single doses of midazolam and metoprolol; Day 2, single doses of pioglitazone, tolbutamide, and omeprazole; Days 5 to 17, daily doses of relacorilant; Day 14, single doses of midazolam and metoprolol (with relacorilant); and, Day 15, single doses of pioglitazone, tolbutamide, and omeprazole (with relacorilant).
This is an open-label, single-sequence, 3-period crossover study conducted in healthy
subjects. Subjects will be screened for eligibility for the study within 21 days before the
first dose of study drug based on entrance criteria specified in Section 4. Eligible subjects
will participate in a single treatment period, in which they will receive the following
treatments:
- Day 1: single doses of midazolam and metoprolol
- Day 2: single doses of pioglitazone, tolbutamide, and omeprazole
- Days 5 to 17: daily doses of relacorilant
- Day 14: single doses of midazolam and metoprolol (with relacorilant)
- Day 15: single doses of pioglitazone, tolbutamide, and omeprazole (with relacorilant)
Blood samples will be collected before dosing and at intervals up to 24 hours after each
midazolam dose, up to 48 hours after each metoprolol, tolbutamide, and omeprazole dose,
and up to 72 hours after each pioglitazone dose for assay of the respective probe
substrates and relevant metabolites. Additional samples will be collected during the
relacorilant dosing period for assay of relacorilant and metabolites to confirm exposure
and at the beginning (before dosing on Day 5) and near the end (Day 14) of the
relacorilant dosing period for assay for 4β-OH cholesterol, a biomarker for CYP
induction.
Safety and tolerability will be monitored using AEs, clinical laboratory evaluations, 12-lead
ECG recordings, vital sign and pulse oximetry measurements, and physical examinations.
Subjects will be admitted to the Clinical Research Unit (CRU) on the morning of Day −1
following an 8-hour fast for baseline assessments and will remain confined until completion
of procedures, 72 hours after the last dose of probe substrate and 24 hours after the last
dose of relacorilant. Subjects may leave the CRU after safety review on the morning of Day
18. Each subject will have a follow-up (FU) visit 14 ± 2 days after the last dose of study
drug.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |